FDA Oncology Announcements

697 Announcements

FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Drugs: Lifyorli (relacorilant) · Glucocorticoid receptor antagonist, nab-paclitaxel
Condition: Gynecologic

FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma

Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, doxorubicin · Anthracycline
Condition: Lymphoid

FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

Trial: MajesTEC-3
Drugs: Tecvayli (teclistamab) · Anti-BCMA-CD3 bispecific antibody, daratumumab hyaluronidase-fihj · Anti-CD38 antibody
Condition: Plasma cell

FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer

Drug: Hernexeos (zongertinib) · ERBB2 inhibitor
Condition: Thoracic

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma

Trial: AMPLIFY
Drugs: Calquence (acalabrutinib) · BTK inhibitor, Venclexta (venetoclax) · Bcl-2 inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Trial: KEYNOTE-B96
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, paclitaxel · Taxane
Condition: Gynecologic

Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

Trial: TRITON3
Drug: Rubraca (rucaparib) · PARP inhibitor
Condition: Genitourinary

FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection

Drug: Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) · Anti-EGFR-HGFR bispecific antibody

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

Drugs: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate, pertuzumab · Anti-HER2 antibody
Condition: Breast

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer

Trial: AMPLITUDE
Drug: Akeega (niraparib and abiraterone acetate) · Multi-ingredient
Condition: Genitourinary

FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

Trial: TRANSCEND FL
Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

Trial: BRUIN CLL-321
Drug: Jaypirca (pirtobrutinib) · BTK inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, fluorouracil · Fluoropyrimidine
Condition: Gastrointestinal

FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer

Trial: KEYNOTE-905
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody, Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer

Trial: DeLLphi-304
Drug: Imdelltra (tarlatamab-dlle) · Anti-DLL3-CD3 bispecific antibody
Condition: Thoracic

FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Trial: KOMET
Drug: KOSELUGO (selumetinib) · MEK inhibitor

FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis

Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor
Condition: Plasma cell

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

Drug: Hyrnuo (sevabertinib) · ERBB2 inhibitor
Condition: Thoracic

FDA approves epcoritamab-bysp for follicular lymphoma indications

Trial: EPCORE FL-1
Drugs: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves new interchangeable biosimilar to Perjeta

Drugs: Poherdy (pertuzumab-dpzb) · Anti-HER2 antibody, Perjeta (pertuzumab) · Anti-HER2 antibody

FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation

Drug: Komzifti (ziftomenib) · KMT2A inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma

Drug: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody
Condition: Plasma cell

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation

Trial: AUGMENT-101
Drug: Revuforj (revumenib) · KMT2A inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma

Trial: DREAMM 7
Drug: Blenrep (belantamab mafodotin-blmf) · Anti-BCMA antibody-drug conjugate
Condition: Plasma cell

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

Drug: Libtayo (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

Trial: IMforte
Drugs: Zepzelca (lurbinectedin) · Alkylating agent, Tecentriq (atezolizumab) · Anti-PD-L1 antibody, Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Trial: EMBER-3
Drug: Inluriyo (imlunestrant) · Estrogen receptor inhibitor
Condition: Breast

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

Trial: MK-3475A-D77
Drug: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug: KOSELUGO (selumetinib) · MEK inhibitor

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

Trial: SunRISe-1
Drug: Inlexzo (gemcitabine intravesical system) · Pyrimidine analog
Condition: Genitourinary

FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations

Drug: Hernexeos (zongertinib) · ERBB2 inhibitor
Condition: Thoracic

FDA grants accelerated approval to dordaviprone for diffuse midline glioma

Drug: Modeyso (dordaviprone) · AKT1 inhibitor
Condition: CNS

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

Trial: LINKER-MM1
Drug: Lynozyfic (linvoseltamab-gcpt) · Anti-BCMA-CD3 bispecific antibody
Condition: Plasma cell

FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Drug: Zegfrovy (sunvozertinib) · EGFR inhibitor
Condition: Thoracic

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer

Drug: Datroway (datopotamab deruxtecan-dlnk) · Anti-TROP2 antibody-drug conjugate
Condition: Thoracic

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

Trial: InMIND
Drugs: Monjuvi (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

Trial: MK-3475-689
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

Trial: ENVISION
Drug: Zusduri (mitomycin intravesical solution) · Alkylating agent
Condition: Genitourinary

FDA approves taletrectinib for ROS1-positive non-small cell lung cancer

Trial: TRUST-II
Drug: Ibtrozi (taletrectinib) · ROS1 inhibitor
Condition: Thoracic

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

Trial: ARASENS
Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

Drugs: Zynyz (retifanlimab-dlwr) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gastrointestinal

FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

Drug: Emrelis (telisotuzumab vedotin-tllv) · Anti-c-Met antibody-drug conjugate
Condition: Thoracic

FDA approves belzutifan for pheochromocytoma or paraganglioma

Trial: MK-6482-015
Drug: Welireg (belzutifan) · HIF-2a inhibitor
Conditions: CNSEndocrine

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

Trial: RAMP 201
Drug: Avmapki Fakzynja Co-pack (avutometinib and defactinib) · Multi-ingredient
Condition: Gynecologic

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

Drugs: penpulimab-kcqx · Anti-PD-1 antibody, gemcitabine · Pyrimidine analog
Condition: Head & Neck

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

Trial: CheckMate 9DW
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

Trial: CheckMate 8HW
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves durvalumab for muscle invasive bladder cancer

Trial: NIAGARA
Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Genitourinary

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

Trial: PSMAfore
Drug: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) · Radioactive agent
Condition: Genitourinary

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinal

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

Trial: MK-3475-811
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor

Trial: MOTION
Drug: Romvimza (vimseltinib) · CSF1R inhibitor
Condition: Sarcoma

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

Trial: ECHELON-3
Drugs: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

Trial: ReNeu
Drug: Gomekli (mirdametinib)

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS

Drugs: Grafapex (treosulfan) · Alkylating agent, fludarabine · Purine analog
Condition: Myeloid

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer

Trial: DB-06
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

Drug: Datroway (datopotamab deruxtecan-dlnk) · Anti-TROP2 antibody-drug conjugate
Condition: Breast

FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer

Trial: CodeBreak300
Drugs: Lumakras (sotorasib) · KRAS inhibitor, Vectibix (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma

Drugs: Calquence (acalabrutinib) · BTK inhibitor, bendamustine · Nitrogen mustard, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

Trial: CheckMate-67T
Drugs: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) · Anti-PD-1 antibody, Opdivo (nivolumab) · Anti-PD-1 antibody

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer

Drug: Ensacove (ensartinib) · ALK inhibitor
Condition: Thoracic

FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients

Drug: Ryoncil (remestemcel-L-rknd) · Cellular therapy
Condition: Other

FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug: Unloxcyt (cosibelimab-ipdl) · Anti-PD-L1 antibody
Condition: Dermatologic

FDA approves durvalumab for limited-stage small cell lung cancer

Trial: ADRIATIC
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma

Drug: Bizengri (zenocutuzumab-zbco) · Anti-HER2-HER3 bispecific antibody
Conditions: GastrointestinalThoracic

FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer

Trial: HERIZON-BTC-01
Drug: Ziihera (zanidatamab-hrii) · Anti-HER2 bispecific antibody
Condition: Gastrointestinal

FDA approves updated drug labeling for fludarabine phosphate under Project Renewal

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

Drug: Revuforj (revumenib) · KMT2A inhibitor
Conditions: LymphoidMyeloidOther hematologic neoplasm

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Drug: Aucatzyl (obecabtagene autoleucel) · Anti-CD19 CAR T-cell
Conditions: LymphoidOther hematologic neoplasm

FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia

Drug: Scemblix (asciminib) · STAMP inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma

Trials: Spotlight, GLOW
Drug: Vyloy (zolbetuximab-clzb) · Anti-CLDN18.2 antibody
Condition: Gastrointestinal

FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

Trial: INAVO120
Drugs: Itovebi (inavolisib) · PI3K alpha inhibitor, palbociclib · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves selpercatinib for medullary thyroid cancer with a RET mutation

Trial: LIBRETTO-531
Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Endocrine

FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

Trial: LAURA
Drug: Tagrisso (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Trial: IMROZ
Drugs: Sarclisa (isatuximab-irfc) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations

Trial: MARIPOSA-2
Drugs: Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody, carboplatin · Platinum agent, pemetrexed · Antifolate
Condition: Thoracic

FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate
Conditions: Other solid neoplasmThoracic

FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer

Trial: NATALEE
Drug: Kisqali (ribociclib) · CDK inhibitor
Condition: Breast

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Drug: Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer

Trial: MARIPOSA
Drugs: Lazcluze (lazertinib) · EGFR inhibitor, Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody
Condition: Thoracic

FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer

Trial: AEGEAN
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves axatilimab-csfr for chronic graft-versus-host disease

Trial: AGAVE-201
Drug: Niktimvo (axatilimab-csfr) · Anti-CSF1R antibody
Condition: Other

FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Drug: Voranigo (vorasidenib) · IDH inhibitor
Condition: CNS

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

Drug: TECELRA (afamitresgene autoleucel) · Anti-MAGE-A4 SPEAR T-cell
Condition: Sarcoma

FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy

Trial: RUBY
Drugs: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma

Trial: Perseus
Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

Trial: EPCORE™ NHL-1
Drug: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer

Drugs: Krazati (adagrasib) · KRAS inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

Drug: Blincyto (blinatumomab) · Anti-CD19-CD3 bispecific antibody
Conditions: LymphoidOther hematologic neoplasm

FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

Trial: DUO-E
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Conditions: GynecologicOther solid neoplasm

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Trial: TRIDENT-1
Drug: AUGTYRO (repotrectinib) · ROS1 inhibitor
Condition: Other solid neoplasm

FDA approves selpercatinib for RET fusion-positive thyroid cancer

Trials: LIBRETTO-001, LIBRETTO-121
Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Endocrine

FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia

Drug: Rytelo (imetelstat) · Telomerase inhibitor
Conditions: Classical hematologyMyeloid

FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

Drug: Retevmo (selpercatinib) · RET inhibitor
Conditions: EndocrineOther solid neoplasm

FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

Trial: DeLLphi-301
Drug: Imdelltra (tarlatamab-dlle) · Anti-DLL3-CD3 bispecific antibody
Condition: Thoracic

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

Trial: innovaTV 301
Drug: Tivdak (tisotumab vedotin-tftv) · Anti-TF antibody-drug conjugate
Condition: Gynecologic

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS

Trials: NETTER-P, NETTER-1
Drug: Lutathera (lutetium Lu 177 dotatate) · Radioactive agent
Condition: Endocrine

FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma

Trial: FIREFLY-1
Drug: Ojemda (tovorafenib) · BRAF inhibitor
Condition: CNS

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

Drug: Anktiva (nogapendekin alfa inbakicept-pmln) · IL-15 receptor alpha fusion protein
Condition: Genitourinary

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer

Drug: Alecensa (alectinib) · ALK inhibitor
Condition: Thoracic

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Trials: DPT02, DESTINY-Lung01, DESTINY-CRC02
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Other solid neoplasm

FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Trial: MIRASOL
Drug: Elahere (mirvetuximab soravtansine-gynx) · Anti-FOLR1 antibody-drug conjugate
Condition: Gynecologic

FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

Drug: Iclusig (ponatinib) · Bcr-Abl inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma

Trial: ROSEWOOD
Drugs: Brukinsa (zanubrutinib) · BTK inhibitor, obinutuzumab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma

Trial: CheckMate901
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, cisplatin · Platinum agent, gemcitabine · Pyrimidine analog
Condition: Genitourinary

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

Drug: Besponsa (inotuzumab ozogamicin) · Anti-CD22 antibody-drug conjugate
Conditions: LymphoidOther hematologic neoplasm

FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications

Trial: PAPILLON
Drugs: Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody, carboplatin · Platinum agent, pemetrexed · Antifolate
Condition: Thoracic

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer

Trial: FLAURA2
Drug: Tagrisso (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma

Drug: Amtagvi (lifileucel) · Mononuclear cell vaccine
Condition: Dermatologic

FDA approves tepotinib for metastatic non-small cell lung cancer

Drug: Tepmetko (tepotinib) · MET inhibitor
Condition: Thoracic

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma

Trial: NAPOLI 3
Drugs: Onivyde (irinotecan liposome) · Topoisomerase I inhibitor, oxaliplatin · Platinum agent
Condition: Gastrointestinal

FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

Drug: Balversa (erdafitinib) · FGFR inhibitor
Condition: Genitourinary

FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer

Trial: KEYNOTE-A18
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gynecologic

FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer

Trial: EV-302
Drugs: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA approves belzutifan for advanced renal cell carcinoma

Drug: Welireg (belzutifan) · HIF-2a inhibitor
Condition: Genitourinary

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma

Drug: IWILFIN (eflornithine) · Ornithine decarboxylase inhibitor
Condition: CNS

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

Drug: Jaypirca (pirtobrutinib) · BTK inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA approves nirogacestat for desmoid tumors

Trial: DeFi
Drug: OGSIVEO (nirogacestat) · Gamma secretase inhibitor
Condition: Sarcoma

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

Drug: Xtandi (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma

Trial: KEYNOTE-859
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves capivasertib with fulvestrant for breast cancer

Trial: CAPItello-291
Drugs: Truqap (capivasertib) · AKT1 inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA approves repotrectinib for ROS1-positive non-small cell lung cancer

Drug: Augtyro (repotrectinib) · ROS1 inhibitor
Condition: Thoracic

FDA approves fruquintinib in refractory metastatic colorectal cancer

Trials: FRESCO-2, FRESCO
Drug: Fruzaqla (fruquintinib) · VEGFR inhibitor
Condition: Gastrointestinal

FDA amends pembrolizumab’s gastric cancer indication

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

Trial: KEYNOTE-966
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves toripalimab-tpzi for nasopharyngeal carcinoma

Drugs: LOQTORZ (toripalimab-tpzi) · Anti-PD-1 antibody, cisplatin · Platinum agent, gemcitabine · Pyrimidine analog
Condition: Head & Neck

FDA approves ivosidenib for myelodysplastic syndromes

Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Myeloid

FDA expands pediatric indication for entrectinib and approves new pellet formulation

Trial: STARTRK-NG
Drug: Rozlytrek (entrectinib) · TRK inhibitor

FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer

Trial: MK-3475-671
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves nivolumab for adjuvant treatment of Stage IIB/C melanoma

Trial: CheckMate76K
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, Mektovi (binimetinib) · MEK inhibitor
Condition: Thoracic

FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia

Drug: Bosulif (bosutinib) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves new and updated indications for temozolomide under Project Renewal

Drug: Temodar (temozolomide) · Triazene

FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma

Drug: Elrexfio (elranatamab-bcmm) · Anti-BCMA-CD3 bispecific antibody
Condition: Plasma cell

FDA approves melphalan as a liver-directed treatment for uveal melanoma

Trial: FOCUS
Drug: HEPZATO KIT (melphalan) · Nitrogen mustard
Condition: Dermatologic

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer

Trial: MAGNITUDE
Drug: Akeega (niraparib and abiraterone acetate) · Multi-ingredient
Condition: Genitourinary

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

Trials: MonumenTAL-1, MonumenTAL-1
Drug: Talvey (talquetamab-tgvs) · Anti-GPRC5D-CD3 bispecific antibody
Condition: Plasma cell

FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions

Trial: ARROW
Drug: Gavreto (pralsetinib) · RET inhibitor
Condition: Thoracic

FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer

Trial: SUNLIGHT
Drugs: LONSURF (trifluridine and tipiracil) · Fluoropyrimidine, bevacizumab · Anti-VEGFR antibody
Condition: Gastrointestinal

FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer

Drugs: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves quizartinib for newly diagnosed acute myeloid leukemia

Trial: QuANTUM-First
Drug: Vanflyta (quizartinib) · FLT3 inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer

Trial: TALAPRO-2
Drugs: Talzenna (talazoparib) · PARP inhibitor, enzalutamide · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas

Drug: Columvi (glofitamab-gxbm) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer

Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Genitourinary

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

Drug: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

Trial: POLARIX
Drugs: Polivy (polatuzumab vedotin-piiq) · Anti-CD79B antibody-drug conjugate, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves omidubicel to reduce time to neutrophil recovery and infection in patients with hematologic malignancies

Drug: Omisirge (omidubicel-onlv)

FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

Trial: EV-103
Drugs: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

Drug: Zynyz (retifanlimab-dlwr) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: CNS

FDA expands early breast cancer indication for abemaciclib with endocrine therapy

Trial: monarchE
Drug: Verzenio (abemaciclib) · CDK inhibitor
Condition: Breast

FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer

Trial: GARNET
Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Conditions: GynecologicOther solid neoplasm

FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer

Trial: TROPiCS-02
Drug: Trodelvy (sacituzumab govitecan-hziy) · Anti-TACSTD2 antibody-drug conjugate
Condition: Breast

FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Trial: EMERALD
Drug: Orserdu (elacestrant) · Estrogen receptor inhibitor
Condition: Breast

FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma

Drug: Jaypirca (pirtobrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer

Trial: PEARLS
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

Drugs: Tukysa (tucatinib) · ERBB2 inhibitor, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma

Trials: SEQUOIA, ALPINE
Drug: Brukinsa (zanubrutinib) · BTK inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

Drug: Lunsumio (mosunetuzumab-axgb) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer

Drug: Adstiladrin (nadofaragene firadenovec-vncg) · Adenovirus vector
Condition: Genitourinary

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC

Drug: Krazati (adagrasib) · KRAS inhibitor
Condition: Thoracic

FDA grants approval to atezolizumab for alveolar soft part sarcoma

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Sarcoma

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

Drug: Rezlidhia (olutasidenib) · IDH inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)

Drug: Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) · Asparagine-specific enzyme

FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer

Trial: SORAYA
Drug: Elahere (mirvetuximab soravtansine-gynx) · Anti-FOLR1 antibody-drug conjugate
Condition: Gynecologic

FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

Drugs: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate, doxorubicin · Anthracycline
Condition: Lymphoid

FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

Trial: POSEIDON
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer

Drug: Libtayo (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma

Trials: MajesTEC-1, MajesTEC-1
Drug: Tecvayli (teclistamab-cqyv) · Anti-BCMA-CD3 bispecific antibody
Condition: Plasma cell

FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma

Trial: HIMALAYA
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, durvalumab · Anti-PD-L1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

Drug: Lytgobi (futibatinib) · FGFR inhibitor
Condition: Gastrointestinal

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer

Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Thoracic

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

Trial: SIOPEL6
Drug: Pedmark (sodium thiosulfate)
Condition: Other solid neoplasm

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

Trial: TOPAZ-1
Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Gastrointestinal

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

Drug: Pemazyre (pemigatinib) · FGFR inhibitor
Conditions: LymphoidMyeloid

FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspension

Drug: Imbruvica (ibrutinib) · BTK inhibitor
Condition: Other

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Thoracic

FDA approves capmatinib for metastatic non-small cell lung cancer

Drug: Tabrecta (capmatinib) · MET inhibitor
Condition: Thoracic

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor

Drug: Xalkori (crizotinib) · ALK inhibitor
Condition: Sarcoma

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

Trial: TRANSFORM
Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: Other solid neoplasm

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

Trial: ELARA
Drug: Kymriah (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications

Trial: CheckMate 648
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Yervoy (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia

Trial: AGILE
Drugs: Tibsovo (ivosidenib) · IDH inhibitor, azacitidine · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia

Drug: Vidaza (azacitidine) · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA approves alpelisib for PIK3CA-related overgrowth spectrum

Trial: EPIK-P1
Drug: Vijoice (alpelisib) · PI3K alpha inhibitor

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

Trial: VISION
Drug: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) · Radioactive agent
Condition: Genitourinary

FDA approves pembrolizumab for advanced endometrial carcinoma

Trial: KEYNOTE 158
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gynecologic

FDA approves Opdualag for unresectable or metastatic melanoma

Trial: RELATIVITY-047
Drug: Opdualag (nivolumab and relatlimab-rmbw) · Multi-ingredient
Condition: Dermatologic

FDA approves olaparib for adjuvant treatment of high-risk early breast cancer

Trial: OlympiA
Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Breast

FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

Trial: CheckMate 816
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

Trial: CARTITUDE-1
Drug: CARVYKTI (ciltacabtagene autoleucel) · Anti-BCMA CAR T-cell
Condition: Plasma cell

FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma

Drug: Kimmtrak (tebentafusp-tebn) · Bispecific gp100 peptide-HLA-directed CD3 T-cell engager
Condition: Dermatologic

FDA approves abatacept for prophylaxis of acute graft versus host disease

Drug: Orencia (abatacept)
Condition: Other

FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma

Trial: KEYNOTE-716
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves rituximab plus chemotherapy for pediatric cancer indications

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Other neoplasm

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma

Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, Kyprolis (carfilzomib) · Proteasome inhibitor
Condition: Plasma cell

FDA approves pafolacianine for identifying malignant ovarian cancer lesions

Drug: Cytalux (pafolacianine)
Condition: Gynecologic

FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor

Trial: AMPECT
Drug: sirolimus protein-bound particles · MTOR inhibitor
Condition: Sarcoma

FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma

Trial: KEYNOTE-564
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia

Drug: Scemblix (asciminib) · STAMP inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves pembrolizumab combination for the first-line treatment of cervical cancer

Trial: KEYNOTE-826
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gynecologic

FDA approves abemaciclib with endocrine therapy for early breast cancer

Drug: Verzenio (abemaciclib) · CDK inhibitor
Condition: Breast

FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Trial: ZUMA-3
Drug: Tecartus (brexucabtagene autoleucel) · Anti-CD19 CAR T-cell
Conditions: LymphoidOther hematologic neoplasm

FDA approves ruxolitinib for chronic graft-versus-host disease

Drug: Jakafi (ruxolitinib) · JAK inhibitor
Condition: Other

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

Drug: Tivdak (tisotumab vedotin-tftv) · Anti-TF antibody-drug conjugate
Condition: Gynecologic

FDA approves cabozantinib for differentiated thyroid cancer

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Condition: Endocrine

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Drug: Exkivity (mobocertinib) · EGFR inhibitor
Condition: Thoracic

FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma

Trial: MAGNOLIA
Drug: Brukinsa (zanubrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

Trial: ASPEN
Drug: Brukinsa (zanubrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Trial: ClarIDHy
Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Gastrointestinal

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

Trial: CheckMate 274
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

Trial: MK-6482-004
Drug: Welireg (belzutifan) · HIF-2a inhibitor

FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma

Trial: CLEAR
Drugs: Lenvima (lenvatinib) · Multikinase inhibitor, Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

Trial: MK-3475-522
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma

Trial: MK-3475-775
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, Lenvima (lenvatinib) · Multikinase inhibitor
Condition: Gynecologic

FDA approves belumosudil for chronic graft-versus-host disease

Drug: Rezurock (belumosudil) · ROCK2 inhibitor
Condition: Other

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

Trial: EMN14
Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, pomalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

Trial: EV-201
Drug: Padcev (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

Drug: Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) · Asparagine-specific enzyme
Conditions: LymphoidOther hematologic neoplasm

FDA approves avapritinib for advanced systemic mastocytosis

Drug: Ayvakit (avapritinib) · PDGFR inhibitor
Condition: Myeloid

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

Drug: Lumakras (sotorasib) · KRAS inhibitor
Condition: Thoracic

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

Drug: Truseltiq (infigratinib) · FGFR inhibitor
Condition: Gastrointestinal

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

Trial: CHRYSALIS
Drug: Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody
Condition: Thoracic

FDA approves nivolumab for resected esophageal or GEJ cancer

Trial: CheckMate 577
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

Trial: LOTIS-2
Drug: Zynlonta (loncastuximab tesirine-lpyl) · Anti-CD19 antibody-drug conjugate
Condition: Lymphoid

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Conditions: GynecologicOther solid neoplasm

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

Trial: CheckMate649
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

Trial: TROPHY U-01
Drug: sacituzumab govitecan · Anti-TACSTD2 antibody-drug conjugate
Condition: Genitourinary

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

Trial: ASCENT
Drug: Trodelvy (sacituzumab govitecan) · Anti-TACSTD2 antibody-drug conjugate
Condition: Breast

FDA approves new dosing regimen for cetuximab

Drug: Erbitux (cetuximab) · Anti-EGFR antibody

FDA approves isatuximab-irfc for multiple myeloma

Trial: IKEMA
Drugs: Sarclisa (isatuximab-irfc) · Anti-CD38 antibody, carfilzomib · Proteasome inhibitor
Condition: Plasma cell

FDA approves idecabtagene vicleucel for multiple myeloma

Drug: Abecma (idecabtagene vicleucel) · Anti-BCMA CAR T-cell
Condition: Plasma cell

FDA approves pembrolizumab for esophageal or GEJ carcinoma

Trial: KEYNOTE-590
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

Drug: Fotivda (tivozanib) · VEGFR inhibitor
Condition: Genitourinary

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

Trial: ZUMA-5
Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves lorlatinib for metastatic ALK-positive NSCLC

Drug: Lorbrena (lorlatinib) · ALK inhibitor
Condition: Thoracic

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

Trial: HORIZON
Drug: Pepaxto (melphalan flufenamide) · Peptidase-enhanced nitrogen mustard
Condition: Plasma cell

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression

Drug: Libtayo (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

Drug: cemiplimab-rwlc · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma

Trial: UNITY-NHL
Drug: Ukoniq (umbralisib) · PI3K delta inhibitor
Condition: Lymphoid

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer

Drug: Tepmetko (tepotinib) · MET inhibitor
Condition: Thoracic

FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma

Trial: CheckMate 9ER
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, Cabometyx (cabozantinib) · VEGFR inhibitor
Condition: Genitourinary

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Gastrointestinal

FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis

Drugs: Darzalex Faspro (daratumumab plus hyaluronidase) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor
Condition: Plasma cell

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

Drug: Xalkori (crizotinib) · ALK inhibitor
Condition: Lymphoid

FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations

Trial: ADAURA
Drug: TAGRISSO (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves relugolix for advanced prostate cancer

Trial: HERO
Drug: ORGOVYX (relugolix) · GnRH antagonist
Condition: Genitourinary

FDA approves selinexor for refractory or relapsed multiple myeloma

Trial: BOSTON
Drugs: XPOVIO (selinexor) · XPO1 inhibitor, bortezomib · Proteasome inhibitor
Condition: Plasma cell

FDA approves margetuximab for metastatic HER2-positive breast cancer

Trial: SOPHIA
Drug: MARGENZA (margetuximab-cmkb) · Anti-HER2 antibody
Condition: Breast

FDA approves pralsetinib for RET-altered thyroid cancers

Trial: ARROW
Drug: GAVRETO (pralsetinib) · RET inhibitor
Condition: Endocrine

FDA approves device for treatment of osteoid osteoma in the extremities

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

Drug: DANYELZA (naxitamab) · Anti-GD2 antibody
Condition: CNS

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

Trial: KEYNOTE-355
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia

Trial: Viale-a
Drugs: VENCLEXTA (venetoclax) · Bcl-2 inhibitor, azacitidine · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA extends approval of pembrolizumab for classical Hodgkin lymphoma

Trial: MK-3475-204
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Lymphoid

FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma

Trial: CheckMate743
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Conditions: Other solid neoplasmThoracic

FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

Condition: Breast

FDA approves pralsetinib for lung cancer with RET gene fusions

Drug: GAVRETO (pralsetinib) · RET inhibitor
Condition: Thoracic

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Trial: QUAZAR AML-001
Drug: ONUREG (azacitidine) · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

Trial: CANDOR
Drugs: KYPROLIS (carfilzomib) · Proteasome inhibitor, DARZALEX (daratumumab) · Anti-CD38 antibody
Condition: Plasma cell

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

Drug: Blenrep (belantamab mafodotin-blmf) · Anti-BCMA antibody-drug conjugate
Condition: Plasma cell

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

Trial: L-MIND
Drugs: MONJUVI (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Lymphoid

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

Drugs: Tecentriq (atezolizumab) · Anti-PD-L1 antibody, cobimetinib · MEK inhibitor, vemurafenib · BRAF inhibitor
Condition: Dermatologic

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma

Trial: ZUMA-2
Drug: TECARTUS (brexucabtagene autoleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes

Drug: INQOVI (decitabine and cedazuridine) · DNA methyltransferase inhibitor
Condition: Myeloid

FDA approves avelumab for urothelial carcinoma maintenance treatment

Trial: JAVELIN Bladder 100
Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer

Trial: KEYNOTE-177
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

Trial: FeDeriCa
Drug: PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) · Anti-HER2 antibody
Condition: Breast

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial: MK-3475-629
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma

Drug: XPOVIO (selinexor) · XPO1 inhibitor
Condition: Lymphoid

FDA granted accelerated approval to tazemetostat for follicular lymphoma

Drug: TAZVERIK (tazemetostat) · EZH inhibitor
Condition: Lymphoid

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Trial: KEYNOTE 158
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

Drug: MYLOTARG (gemtuzumab ozogamicin) · Anti-CD33 antibody-drug conjugate
Condition: Myeloid

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

Drug: ZEPZELCA (lurbinectedin) · Alkylating agent
Condition: Thoracic

FDA approves nivolumab for esophageal squamous cell carcinoma

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

Trial: RELAY
Drugs: CYRAMZA (ramucirumab) · Anti-VEGFR antibody, erlotinib · EGFR inhibitor
Condition: Thoracic

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial: IMbrave150
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, AVASTIN (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

Trial: CheckMate 9LA
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA approves brigatinib for ALK-positive metastatic NSCLC

Trial: ALTA-1L
Drug: ALUNBRIG (brigatinib) · ALK inhibitor
Condition: Thoracic

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Genitourinary

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

Trial: CheckMate 227
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

Trial: TRITON2
Drug: RUBRACA (rucaparib) · PARP inhibitor
Condition: Genitourinary

FDA approves ripretinib for advanced gastrointestinal stromal tumor

Trial: INVICTUS
Drug: QINLOCK (ripretinib) · PDGFR inhibitor
Condition: Sarcoma

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug: POMALYST (pomalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Sarcoma

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

Trial: DUO-O
Drugs: LYNPARZA (olaparib) · PARP inhibitor, bevacizumab · Anti-VEGFR antibody
Condition: Gynecologic

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

Drug: RETEVMO (selpercatinib) · RET inhibitor
Condition: Endocrine

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

Drug: TABRECTA (capmatinib) · MET inhibitor
Condition: Thoracic

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody
Condition: Plasma cell

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

Drug: ZEJULA (niraparib) · PARP inhibitor
Condition: Gynecologic

FDA approves new dosing regimen for pembrolizumab

Trial: KEYNOTE-555
Drugs: KEYTRUDA (400 mg every six weeks for pembrolizumab) , KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

Drug: TRODELVY (sacituzumab govitecan-hziy) · Anti-TACSTD2 antibody-drug conjugate
Condition: Breast

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

Drugs: IMBRUVICA (ibrutinib) · BTK inhibitor, rituximab · Anti-CD20 antibody
Conditions: LymphoidOther hematologic neoplasm

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

Drug: PEMAZYRE (pemigatinib) · FGFR inhibitor
Condition: Gastrointestinal

FDA approves tucatinib for patients with HER2-positive metastatic breast cancer

Trial: HER2CLIMB
Drug: TUKYSA (tucatinib) · ERBB2 inhibitor
Condition: Breast

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial: Olympus
Drug: JELMYTO (mitomycin) · Alkylating agent
Condition: Genitourinary

FDA approves selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug: KOSELUGO (selumetinib) · MEK inhibitor

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

Trial: BEACON CRC
Drugs: BRAFTOVI (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves luspatercept-aamt for anemia in adults with MDS

Trial: MEDALIST
Drug: REBLOZYL (luspatercept-aamt) · TGF-beta inhibitor
Conditions: Classical hematologyMyeloid

FDA approves durvalumab for extensive-stage small cell lung cancer

Trial: CASPIAN
Drugs: IMFINZI (durvalumab) · Anti-PD-L1 antibody, etoposide · Topoisomerase II inhibitor
Condition: Thoracic

FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma

Trial: CheckMate040
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Gastrointestinal

FDA approves isatuximab-irfc for multiple myeloma

Trial: ICARIA-MM
Drugs: SARCLISA (isatuximab-irfc) · Anti-CD38 antibody, pomalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA approves neratinib for metastatic HER2-positive breast cancer

Trial: NALA
Drugs: NERLYNX (neratinib) · ERBB2 inhibitor, capecitabine · Fluoropyrimidine
Condition: Breast

FDA approves tazemetostat for advanced epithelioid sarcoma

Drug: TAZVERIK (tazemetostat) · EZH inhibitor
Condition: Sarcoma

FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation

Drug: AYVAKITTM (avapritinib) · PDGFR inhibitor
Condition: Sarcoma

FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma

Trial: POLO
Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Gastrointestinal

FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm

Drug: ELZONRIS (tagraxofusp-erzs) · IL-3 fused immunotoxin
Condition: Myeloid

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer

Trial: DESTINY-Breast01
Drug: ENHERTU (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer

Trial: EV-201
Drug: PADCEV (enfortumab vedotin-ejfv) · Anti-nectin-4 antibody-drug conjugate
Condition: Genitourinary

FDA approves enzalutamide for metastatic castration-sensitive prostate cancer

Trial: ARCHES
Drug: XTANDI (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations

Trial: IMpower130
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, paclitaxel protein-bound · Taxane, carboplatin · Platinum agent
Condition: Thoracic

FDA approves voxelotor for sickle cell disease

Trial: GBT_HOPE
Drug: Oxbryta (voxelotor) · Hemoglobin S polymerization inhibitor
Condition: Classical hematology

Project Orbis: FDA approves acalabrutinib for CLL and SLL

Trial: ElevateTN
Drug: CALQUENCE (acalabrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves givosiran for acute hepatic porphyria

Drug: GIVLAARI (givosiran)

FDA approves crizanlizumab-tmca for sickle cell disease

Trial: SUSTAIN
Drug: ADAKVEO (crizanlizumab-tmca) · Anti-P-selectin antibody
Condition: Classical hematology

FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma

Drug: BRUKINSA (zanubrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves luspatercept-aamt for anemia in patients with beta thalassemia

Trial: BELIEVE
Drug: REBLOZYL (luspatercept-aamt) · TGF-beta inhibitor
Condition: Classical hematology

FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases

FDA approves niraparib for HRD-positive advanced ovarian cancer

Trial: QUADRA
Drug: ZEJULA (niraparib) · PARP inhibitor
Condition: Gynecologic

FDA approves daratumumab for transplant-eligible multiple myeloma

Trial: Cassiopeia
Drugs: DARZALEX (daratumumab) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor
Condition: Plasma cell

FDA approves apalutamide for metastatic castration-sensitive prostate cancer

Trial: TITAN
Drug: ERLEADA (apalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

Simultaneous review decisions for pembrolizumab plus lenvatinib in Australia, Canada and US

Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, LENVIMA (lenvatinib) · Multikinase inhibitor

FDA approves fedratinib for myelofibrosis

Trial: JAKARTA
Drug: INREBIC (fedratinib) · JAK inhibitor
Condition: Myeloid

FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC

Trials: STARTRK-1, STARTRK-2
Drug: ROZLYTREK (entrectinib) · TRK inhibitor
Conditions: Other solid neoplasmThoracic

FDA approves pexidartinib for tenosynovial giant cell tumor

Trial: ENLIVEN
Drug: TURALIO (pexidartinib) · Multikinase inhibitor
Condition: Sarcoma

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

Trial: ARAMIS
Drug: NUBEQA (darolutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

Trials: KEYNOTE-181, KEYNOTE-180
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to selinexor for multiple myeloma

Trial: STORM
Drug: XPOVIO (selinexor) · XPO1 inhibitor
Condition: Plasma cell

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

Drugs: DARZALEX (daratumumab) · Anti-CD38 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA approves pembrolizumab for metastatic small cell lung cancer

Trial: MK-3475-028
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma

Drugs: POLIVY (polatuzumab vedotin-piiq) · Anti-CD79B antibody-drug conjugate, bendamustine · Nitrogen mustard, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma

Trial: MK-3475-048
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation

Drug: XOSPATA (gilteritinib) · FLT3 inhibitor
Condition: Myeloid

FDA approves lenalidomide for follicular and marginal zone lymphoma

Trials: AUGMENT, MAGNIFY
Drugs: REVLIMID (lenalidomide) · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves alpelisib for metastatic breast cancer

Trial: SOLAR-1
Drugs: PIQRAY (alpelisib) · PI3K alpha inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA approves ruxolitinib for acute graft-versus-host disease

Drug: JAKAFI (ruxolitinib) · JAK inhibitor
Condition: Other

FDA approves dalteparin sodium for VTE in pediatric patients

Drug: FRAGMIN (dalteparin sodium) · Low molecular weight heparin
Condition: Classical hematology

FDA approves venetoclax for CLL and SLL

Drug: VENCLEXTA (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

FDA approves avelumab plus axitinib for renal cell carcinoma

Trial: JAVELIN Renal 101
Drugs: BAVENCIO (avelumab) · Anti-PD-L1 antibody, axitinib · VEGFR inhibitor
Condition: Genitourinary

FDA approves ramucirumab for hepatocellular carcinoma

Trial: REACH-2
Drug: CYRAMZA (ramucirumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

FDA approves ado-trastuzumab emtansine for early breast cancer

Drug: KADCYLA (ado-trastuzumab emtansine) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation

Drug: TIBSOVO (ivosidenib) · IDH inhibitor
Condition: Myeloid

FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma

Trial: KEYNOTE-426
Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, axitinib · VEGFR inhibitor
Condition: Genitourinary

FDA grants accelerated approval to erdafitinib for metastatic urothelial carcinoma

Drug: BALVERSA (erdafitinib) · FGFR inhibitor
Condition: Genitourinary

FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%)

Trial: Keynote 042
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves atezolizumab for extensive-stage small cell lung cancer

Trial: IMpower133
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, carboplatin · Platinum agent, etoposide · Topoisomerase II inhibitor
Condition: Thoracic

FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, paclitaxel protein-bound · Taxane
Condition: Breast

FDA approves new formulation of Herceptin for subcutaneous use

Trial: SafeHER
Drug: Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) · Anti-HER2 antibody

FDA approves Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

Drug: LONSURF (trifluridine/ tipiracil) · Fluoropyrimidine
Condition: Gastrointestinal

FDA approves pembrolizumab for adjuvant treatment of melanoma

Trial: MK-3475-054
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approved caplacizumab-yhdp

Trial: HERCULES
Drug: CABLIVI (caplacizumab-yhdp) · Anti-vWF antibody

FDA approves cabozantinib for hepatocellular carcinoma

Trial: CELESTIAL
Drug: CABOMETYX (cabozantinib) · VEGFR inhibitor
Condition: Gastrointestinal

FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm

Drug: ELZONRIS (tagraxofusp-erzs) · IL-3 fused immunotoxin
Condition: Myeloid

FDA approves longer-acting calaspargase pegol-mknl for ALL

Drug: ASPARLAS (calaspargase pegol-mknl) · Asparagine-specific enzyme

FDA approves pembrolizumab for Merkel cell carcinoma

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based

Trial: SOLO-1
Drug: LYNPARZA (olaparib) · PARP inhibitor
Condition: Gynecologic

FDA approves romiplostim for pediatric patients with immune thrombocytopenia

Drug: NPLATE (romiplostim) · Megakaryocyte growth factor
Condition: Classical hematology

FDA approves Herzuma as a biosimilar to Herceptin

Drugs: Herzuma (trastuzumab-pkrb) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody

Atezolizumab (TECENTRIQ)

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody

FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutatation

Drug: XOSPATA (gilteritinib) · FLT3 inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma

Drugs: Truxima (rituximab-abbs) · Anti-CD20 antibody, Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Drug: VITRAKVI (larotrectinib) · TRK inhibitor
Condition: Other solid neoplasm

FDA approves glasdegib for AML in adults age 75 or older or who have comorbidities

Drug: DAURISMO (glasdegib) · Hedgehog pathway inhibitor
Condition: Myeloid

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

Trial: MURANO
Drug: VENCLEXTA (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

FDA approves emapalumab for hemophagocytic lymphohistiocytosis

Drugs: GAMIFANT (emapalumab) · Anti-IFNg antibody, refractory
Conditions: Classical hematologyMyeloid

FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL

Trial: ECHELON-2
Drug: ADCETRIS (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

Trial: KEYNOTE-224
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA approves lorlatinib for second- or third-line treatment of ALK-positive metastatic NSCLC

Drug: LORBRENA (lorlatinib) · ALK inhibitor
Condition: Thoracic

FDA approves pembrolizumab in combination with chemotherapy for first-line treatment of metastatic squamous NSCLC

Trial: KEYNOTE-407
Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, carboplatin · Platinum agent
Condition: Thoracic

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

Trial: EMBRACA
Drug: TALZENNA (talazoparib) · PARP inhibitor
Condition: Breast

FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors

Trials: HAVEN 3, HAVEN 4
Drug: HEMLIBRA (emicizumab-kxwh) · Factor IXa/Xa bridging antibody
Condition: Classical hematology

FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug: LIBTAYO (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves dacomitinib for metastatic non-small cell lung cancer

Drug: VIZIMPRO (dacomitinib) · EGFR inhibitor
Condition: Thoracic

duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Trial: DYNAMO + R
Drug: COPIKTRA (duvelisib) · PI3K delta inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia

Drug: LUMOXITI (moxetumomab pasudotox-tdfk) · Anti-CD22 immunotoxin
Conditions: LymphoidOther hematologic neoplasm

FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC

Trial: MK-3475-189
Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate
Condition: Thoracic

FDA approves lenvatinib for unresectable hepatocellular carcinoma

Drug: Lenvima (lenvatinib) · Multikinase inhibitor
Condition: Gastrointestinal

FDA updates prescribing information for Keytruda and Tecentriq

FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves mogamulizumab-kpkc for mycosis fungoides or Sézary syndrome

Drug: Poteligeo (mogamulizumab-kpkc) · Anti-CCR4 antibody
Condition: Lymphoid

FDA approves lusutrombopag for thrombocytopenia in adults with chronic liver disease

Trial: L-PLUS 2
Drug: Mulpleta (lusutrombopag) · Megakaryocyte growth factor
Condition: Classical hematology

FDA approves iobenguane I 131 for rare adrenal gland tumors

Drug: AZEDRA (iobenguane I 131) · Radioactive agent
Condition: Endocrine

FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia

Drug: Tibsovo (ivosidenib) · IDH inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer

Trials: MONALEESA-7, MONALEESA-3
Drug: Kisqali (ribociclib) · CDK inhibitor
Condition: Breast

FDA approves enzalutamide for castration-resistant prostate cancer

Drug: XTANDI (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

Trial: CheckMate142
Drugs: YERVOY (ipilimumab) · Anti-CTLA-4 antibody, nivolumab · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves encorafenib and binimetinib in combination for unresectable or metastatic melanoma with BRAF mutations

Trial: COLUMBUS
Drug: BRAFTOVI and MEKTOVI (encorafenib and binimetinib) · BRAF inhibitor
Condition: Dermatologic

FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients

Condition: Genitourinary

FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

Trial: MK-3475-170
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Lymphoid

FDA approves bevacizumab in combination with chemotherapy for ovarian cancer

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves pembrolizumab for advanced cervical cancer with disease progression during or after chemotherapy

Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Gynecologic

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

Drug: VENCLEXTA (venetoclax) · Bcl-2 inhibitor
Condition: Lymphoid

FDA approves Mircera for anemia associated with chronic kidney disease in pediatric patients on dialysis

Drug: Mircera (methoxy polyethylene glycol-epoetin beta)
Condition: Classical hematology

FDA approves first biosimilar to Neulasta to decrease the risk of infection during cancer treatment

Drugs: Fulphila (pegfilgrastim-jmdb) · Granulocyte colony-stimulating factor, Neulasta (pegfilgrastim) · Granulocyte colony-stimulating factor

FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease

Drug: Doptelet (avatrombopag) · Megakaryocyte growth factor
Condition: Classical hematology

FDA approves Retacrit as a biosimilar to Epogen/Procrit

Drug: Retacrit (epoetin alfa-epbx) · Erythrocyte growth factor

FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation

Drugs: TAFINLAR (dabrafenib) · BRAF inhibitor, MEKINIST (trametinib) · MEK inhibitor
Condition: Endocrine

FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma

Trial: JULIET
Drug: KYMRIAH (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves dabrafenib plus trametinib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations

Trial: COMBI-AD
Drugs: TAFINLAR (dabrafenib) · BRAF inhibitor, MEKINIST (trametinib) · MEK inhibitor
Condition: Dermatologic

FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations

Trial: FLAURA
Drug: Tagrisso (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves fostamatinib tablets for ITP

Trials: FIT, FIT
Drug: TAVALISSE (fostamatinib disodium hexahydrate) · SYK inhibitor
Condition: Classical hematology

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Genitourinary

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

Trial: EXIST-3
Drugs: Afinitor Disperz (everolimus tablets for oral suspension) · MTOR inhibitor, Afinitor Disperz (oral suspension)

FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

Trial: ARIEL3
Drug: Rubraca (rucaparib) · PARP inhibitor
Condition: Gynecologic

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

Trial: BLAST
Drug: Blincyto (blinatumomab) · Anti-CD19-CD3 bispecific antibody
Conditions: LymphoidOther hematologic neoplasm

FDA approves nilotinib for pediatric patients with newly diagnosed or resistant/intolerant Ph+ CML in chronic phase

Trial: DIALOG
Drug: TASIGNA (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

Brentuximab Vedotin

Drug: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate

FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

Drug: VERZENIO (abemaciclib) · CDK inhibitor
Condition: Breast

FDA approves durvalumab after chemoradiation for unresectable stage III NSCLC

Trial: PACIFIC
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves apalutamide for non-metastatic castration-resistant prostate cancer

Trial: SPARTAN
Drug: Erleada (apalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

Drug: Zytiga (abiraterone acetate) · CYP17 inhibitor
Condition: Genitourinary

FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS

Trial: NETTER-1
Drug: LUTATHERA (lutetium Lu 177 dotatate) · Radioactive agent
Condition: Endocrine

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer

Trial: OlympiAD
Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Breast

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

Drug: Gilotrif (afatinib) · EGFR inhibitor
Condition: Thoracic

Nilotinib label update to include treatment discontinuation recommendations for CML with sustained molecular responses

Trials: ENESTfreedom, ENESTop
Drug: Tasigna (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA approves hydroxyurea for treatment of pediatric patients with sickle cell anemia

Trial: ESCORT-HU
Drug: Siklos (hydroxyurea) · Antimetabolite
Condition: Classical hematology

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma

Trial: CheckMate 238
Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

Trial: APHINITY
Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody
Condition: Breast

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

Drug: BOSULIF (bosutinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Condition: Genitourinary

FDA approves Ogivri as a biosimilar to Herceptin

Drugs: Ogivri (trastuzumab-dkst) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic

FDA approves obinutuzumab for previously untreated follicular lymphoma

Drug: GAZYVA (obinutuzumab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves sunitinib malate for adjuvant treatment of renal cell carcinoma

Drug: Sutent (sunitinib malate) · VEGFR inhibitor
Condition: Genitourinary

FDA approves emicizumab-kxwh for prevention and reduction of bleeding in patients with hemophilia A with factor VIII inhibitors

Trials: HAVEN 1, HAVEN 2
Drug: HEMLIBRA (emicizumab-kxwh) · Factor IXa/Xa bridging antibody
Condition: Classical hematology

FDA approves dasatinib for pediatric patients with CML

Drug: SPRYCEL (dasatinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma

Drug: ADCETRIS (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

FDA granted approval to vemurafenib for Erdheim-Chester Disease

Drug: ZELBORAF (vemurafenib) · BRAF inhibitor
Condition: Myeloid

Alectinib approved for (ALK) positive metastatic non-small cell lung cancer (NSCLC)

Trial: ALEX
Drug: ALECENSA (alectinib) · ALK inhibitor
Condition: Thoracic

FDA grants accelerated approval to acalabrutinib for mantle cell lymphoma

Drug: Calquence (acalabrutinib) · BTK inhibitor
Condition: Lymphoid

FDA approves axicabtagene ciloleucel for large B-cell lymphoma

Drug: YESCARTA (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves abemaciclib for HR-positive, HER2-negative breast cancer

Drugs: VERZENIO (abemaciclib) · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA grants accelerated approval to nivolumab for HCC previously treated with sorafenib

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

Trial: KEYNOTE-059
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to copanlisib for relapsed follicular lymphoma

Drug: ALIQOPA (copanlisib) · PI3K delta inhibitor
Condition: Lymphoid

FDA approves lower dose of cabazitaxel for prostate cancer

Condition: Genitourinary

FDA approves first biosimilar for cancer treatment

Drugs: Mvasi (bevacizumab-awwb) · Anti-VEGFR antibody, Avastin (bevacizumab) · Anti-VEGFR antibody

FDA Approves Gemtuzumab Ozogamicin for CD33-positive AML

Drugs: Mylotarg (gemtuzumab ozogamicin) · Anti-CD33 antibody-drug conjugate, daunorubicin · Anthracycline, cytarabine · Pyrimidine analog
Condition: Myeloid

FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome

Drug: KYMRIAH (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Gynecologic

FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL

Drug: BESPONSA (inotuzumab ozogamicin) · Anti-CD22 antibody-drug conjugate
Condition: Lymphoid

FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML

Trial: 301
Drug: VYXEOS (daunorubicin and cytarabine) · Anthracycline
Condition: Myeloid

FDA expands ibrutinib indications to chronic GVHD

Drug: Imbruvica (ibrutinib) · BTK inhibitor
Condition: Other

FDA granted regular approval to enasidenib for the treatment of relapsed or refractory AML

Drug: IDHIFA (enasidenib) · IDH inhibitor
Condition: Myeloid

FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Conditions: GastrointestinalOther solid neoplasm

FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer

Trial: ExteNET
Drug: NERLYNX (neratinib) · ERBB2 inhibitor
Condition: Breast

FDA grants regular approval to blinatumomab and expands indication to include Philadelphia chromosome-positive B cell

Drug: BLINCYTO (blinatumomab) · Anti-CD19-CD3 bispecific antibody

FDA granted marketing approval to the Praxis Extended RAS Panel

FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients

Trial: APEX
Drug: BEVYXXA (betrixaban) · Factor Xa inhibitor
Condition: Classical hematology

FDA grants regular approval to dabrafenib and trametinib combination for metastatic NSCLC with BRAF V600E mutation

Drugs: TAFINLAR (dabrafenib) · BRAF inhibitor, MEKINIST (trametinib) · MEK inhibitor
Condition: Thoracic

FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL and CLL

Drug: RITUXAN HYCELA (rituximab and hyaluronidase human) · Anti-CD20 antibody
Condition: Lymphoid

Aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas

Drug: Gleolan (aminolevulinic acid hydrochloride)
Condition: CNS

FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC

Drug: ZYKADIA (ceritinib) · ALK inhibitor
Condition: Thoracic

FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody

Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Genitourinary

Pembrolizumab (Keytruda) 5-10-2017

Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate, carboplatin · Platinum agent

FDA grants accelerated approval to avelumab for urothelial carcinoma

Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

Durvalumab (Imfinzi)

Drug: IMFINZI (durvalumab) · Anti-PD-L1 antibody

Rucaparib

Drug: RUBRACA (rucaparib) · PARP inhibitor

Daratumumab (DARZALEX)

Drugs: DARZALEX (daratumumab) · Anti-CD38 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)

Nivolumab for SCCHN

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Head & Neck

Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody

Olaratumab (LARTRUVO)

Drug: LARTRUVO (olaratumab) · Anti-PDGFR antibody

Erlotinib (Tarceva)

Drug: TARCEVA (erlotinib) · EGFR inhibitor

Atezolizumab (TECENTRIQ)

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody

Modification of the Dosage Regimen for Nivolumab

pembrolizumab (KEYTRUDA)

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody

cobas EGFR Mutation Test v2

Drug: Roche Molecular Systems (cobas EGFR Mutation Test v2)

Atezolizumab for Urothelial Carcinoma

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Genitourinary

Nivolumab (Opdivo) for Hodgkin Lymphoma

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Lymphoid

Lenvatinib in combination with Everolimus

Drugs: Lenvima (lenvatinib) · Multikinase inhibitor, everolimus · MTOR inhibitor

Cabozantinib (CABOMETYX)

Drug: CABOMETYX (cabozantinib) · VEGFR inhibitor

Venetoclax (Venclexta) Tablets

Drug: VENCLEXTA tablets (venetoclax) · Bcl-2 inhibitor

Defitelio (defibrotide sodium)

Drug: Defitelio (defibrotide sodium) · Profibrinolytic

FDA Approves Crizotinib Capsules

Drug: Xalkori (crizotinib) · ALK inhibitor

Everolimus (Afinitor)

Drug: Afinitor (everolimus) · MTOR inhibitor

Obinutuzumab

Drugs: Gazyva (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard

Palbociclib (IBRANCE Capsules)

Drugs: IBRANCE Capsules (palbociclib) · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor

Eribulin

Drug: HALAVEN (eribulin) · Non-taxane microtubule dynamics inhibitor

Ofatumumab (Arzerra Injection)

Drug: Arzerra (ofatumumab) · Anti-CD20 antibody

Pembrolizumab label updated with new clinical trial information

Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody

Alectinib

Drug: ALECENSA capsules (alectinib) · ALK inhibitor

Uridine Triacetate

Drug: VISTOGARD granules (uridine triacetate) · Fluoropyrimidine

Elotuzumab

Drugs: EMPLICITI (elotuzumab) · Anti-SLAMF7 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)

Necitumumab

Drugs: PORTRAZZA (necitumumab) · Anti-EGFR antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent

Nivolumab (Opdivo Injection)

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody

Ixazomib

Drugs: NINLARO (ixazomib) · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)

Trametinib/Dabrafenib

Drugs: Mekinist (trametinib) · MEK inhibitor, Tafinlar (dabrafenib) · BRAF inhibitor

Daratumumab injection

Drug: DARZALEX (daratumumab) · Anti-CD38 antibody

Osimertinib

Drug: TAGRISSO (osimertinib) · EGFR inhibitor

Cobimetinib

Drug: COTELLIC Tablets (cobimetinib) · MEK inhibitor

Ipilimumab (Yervoy)

Talimogene Laherparepvec

Drug: IMLYGIC (talimogene laherparepvec) · Oncolytic viral therapy

Trabectedin

Drug: Yondelis (trabectedin) · Alkylating agent

Irinotecan liposome injection

Drug: ONIVYDE (irinotecan liposome) · Topoisomerase I inhibitor

Idarucizumab

Drug: Praxbind (idarucizumab) · Anti-dabigatran antibody fragment

Nivolumab Injection

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody

Pembrolizumab injection

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody

Nivolumab in combination with ipilimumab

Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, ipilimumab · Anti-CTLA-4 antibody

Trifluridine/tipiracil

Drug: LONSURF (trifluridine/tipiracil) · Fluoropyrimidine

Eltrombopag / Promacta

Drug: Promacta for oral suspension (eltrombopag) · Megakaryocyte growth factor

Brentuximab Vedotin Approved for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression

Drug: ADCETRIS (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate
Condition: Lymphoid

Sonidegib

Drug: Odomzo Capsules (sonidegib) · SMO inhibitor

Carfilzomib /Kyprolis

Drugs: Kyprolis (carfilzomib) · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)

Gefitinib (Iressa)

Drug: IRESSA (gefitinib) · EGFR inhibitor

Ramucirumab mCRC

Condition: Gastrointestinal

Dinutuximab

Drug: Unituxin (dinutuximab) · Anti-GD2 antibody

Filgrastim-sndz

Drug: ZARXIO (filgrastim-sndz) · Granulocyte colony-stimulating factor

Nivolumab (Opdivo)

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody

Panobinostat

Drugs: FARYDAK capsules (panobinostat) · HDAC inhibitor, bortezomib · Proteasome inhibitor

Lenvatinib (Lenvima)

Drug: Lenvima (lenvatinib) · Multikinase inhibitor

Palbociclib

Drugs: IBRANCE (palbociclib) · CDK inhibitor, letrozole · Aromatase inhibitor third generation

Ibrutinib (Imbruvica)

Drug: Imbruvica Capsules (ibrutinib) · BTK inhibitor

Nivolumab

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody

Olaparib

Drug: Lynparza (olaparib) · PARP inhibitor

Lanreotide

Drug: Somatuline Depot (lanreotide) · Somatostatin analog

Ramucirumab (Cyramza)

Drugs: Cyramza (ramucirumab) · Anti-VEGFR antibody, docetaxel · Taxane, paclitaxel · Taxane

FDA Approves Ruxolitinib

Drug: Jakafi (ruxolitinib) · JAK inhibitor

Blinatumomab

Drug: BLINCYTO (blinatumomab) · Anti-CD19-CD3 bispecific antibody

Bevacizumab solution in combination with Paclitaxel

Drugs: Avastin (bevacizumab solution for intravenous infusion) · Anti-VEGFR antibody, Avastin (intravenous infusion) , paclitaxel · Taxane

Ramucirumab in combination with paclitaxel

Drugs: Cyramza (ramucirumab) · Anti-VEGFR antibody, paclitaxel · Taxane

Pembrolizumab

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody

Bevacizumab solution

Drugs: Avastin (bevacizumab solution for intravenous infusion) · Anti-VEGFR antibody, Avastin (intravenous infusion)

Idelalisib

Drugs: Zydelig tablets (idelalisib) · PI3K delta inhibitor, rituximab · Anti-CD20 antibody

Belinostat

Drug: BELEODAQ (belinostat) · HDAC inhibitor

FDA Approves Ceritinib

Drug: ZYKADIA (ceritinib) · ALK inhibitor

Mercaptopurine

Drug: Purixan (mercaptopurine) · Purine analog

Siltuximab

Drug: Sylvant Injection Janssen Biotech (siltuximab) · Anti-IL-6 antibody

Ramucirumab

Drug: Cyramza (ramucirumab) · Anti-VEGFR antibody

FDA Approves Ofatumumab

Drugs: Arzerra (ofatumumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard

Sorafenib (NEXAVAR)

Drug: NEXAVAR tablets (sorafenib) · VEGFR inhibitor

FDA Approves Crizotinib

Drug: Xalkori (crizotinib) · ALK inhibitor

Ibrutinib (IMBRUVICA)

Drug: IMBRUVICA (ibrutinib) · BTK inhibitor

FDA grants accelerated approval to Ibrutinib (Imbruvica)

Drug: IMBRUVICA (Ibrutinib) · BTK inhibitor

Gazyva (obinutuzumab)

Drugs: GAZYVA (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard

Inclusig (ponatinib)

Doxorubicin Hydrochloride Liposome Injection Availability

Pertuzumab Injection

Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane

Paclitaxel

Drug: Abraxane (paclitaxel) · Taxane

FDA Approves Afatinib

Drug: Gilotrif tablets (afatinib) · EGFR inhibitor

FDA Approves Denosumab

Drug: Xgeva (denosumab) · Anti-RANKL antibody

FDA Approves Lenalidomide

Drug: REVLIMID (lenalidomide) · Immunomodulatory drugs (IMiDs)

Dabrafenib

Drug: TAFINLAR capsule (dabrafenib) · BRAF inhibitor

FDA Approves Trametinib

Drug: MEKINIST tablet (trametinib) · MEK inhibitor

Radium Ra 223 dichloride

Drug: Xofigo (radium Ra 223 dichloride)

FDA Approves Erlotinib

Drug: Tarceva (erlotinib) · EGFR inhibitor

FDA Approves Ado-Trastuzumab Emtansine

Drug: KADCYLA (ado-trastuzumab emtansine) · Anti-HER2 antibody-drug conjugate

Pomalidomide

Drug: POMALYST capsules (pomalidomide) · Immunomodulatory drugs (IMiDs)

Doxorubicin Hydrochloride Liposome (Injection)

Drug: doxorubicin hydrochloride liposome · Anthracycline

Bevacizumab

Drug: Avastin (bevacizumab) · Anti-VEGFR antibody

FDA Approves Ponatinib

Drug: Iclusig tablets (ponatinib) · Bcr-Abl inhibitor

Expanded Approval forAbiraterone Acetate

Drug: Zytiga Tablets (abiraterone acetate) · CYP17 inhibitor

Cabozantinib

Drug: COMETRIQ capsules (cabozantinib) · VEGFR inhibitor

Omacetaxine Mepesuccinate

Drug: SYNRIBO (omacetaxine mepesuccinate) · Bcr-Abl inhibitor

Rituximab Infusion

Drug: Rituxan (rituximab) · Anti-CD20 antibody

Pemetrexed

Drug: ALIMTA (pemetrexed) · Antifolate

Paclitaxel (Abraxane)

Drugs: ABRAXANE (albumin-bound) , carboplatin · Platinum agent

Regorafenib

Drug: Stivarga tablets (regorafenib) · Multikinase inhibitor

Bosutinib tablets

Drug: Bosulif (bosutinib) · Bcr-Abl inhibitor

Enzalutamide (XTANDI Capsules)

Drug: XTANDI Capsules (enzalutamide) · Second-generation nonsteroidal antiandrogen

Everolimus for Tuberous Sclerosis Complex (TSC)

Drug: Afinitor Disperz (everolimus tablets for oral suspension) · MTOR inhibitor

vinCRIStine sulfate LIPOSOME injection

Drug: Marqibo (vinCRIStine sulfate LIPOSOME) · Vinca alkaloid

Ziv-Aflibercept

Drug: Zaltrap (ziv-aflibercept) · VEGFR inhibitor

Carfilzomib

Drug: Kyprolis (carfilzomib) · Proteasome inhibitor

Everolimus 2012

Drugs: Afinitor (everolimus) · MTOR inhibitor, exemestane · Aromatase inhibitor third generation

Cetuximab in Combination with Folfiri / Therascreen

Drug: Erbitux (cetuximab) · Anti-EGFR antibody

FDA approved L-glutamine powder for the treatment of sickle cell disease

Drug: Endari (L-glutamine oral powder) · Replacement therapy
Condition: Classical hematology

FDA Approves Pertuzumab

Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane

FDA approves Pazopanib for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy

Drug: VOTRIENT (pazopanib) · VEGFR inhibitor
Condition: Sarcoma

Everolimus (2012)

Drug: Afinitor tablets (everolimus) · MTOR inhibitor

Doxorubicin hydrochloride liposome injection

Imatinib Mesylate Tablets

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor

Vismodegib

Drug: ERIVEDGE Capsule (vismodegib) · SMO inhibitor

Axitinib

Drug: Inlyta (axitinib) · VEGFR inhibitor

Glucarpidase

Drug: Voraxaze (glucarpidase) · Chemotherapy protective agent

Methotrexate Safety information

Romiplostim/Eltrombopag

Drugs: Nplate for subcutaneous (romiplostim) · Megakaryocyte growth factor, Promacta tablets (eltrombopag) · Megakaryocyte growth factor

asparaginase Erwinia chrysanthemi

Drug: Erwinaze (asparaginase erwinia chrysanthemi) · Asparagine-specific enzyme

Ruxolitinib

Drug: Jakafi oral tablets (ruxolitinib) · JAK inhibitor

Cetuximab (Erbitux)

Drug: Erbitux (cetuximab) · Anti-EGFR antibody

Deferiprone

Drug: Ferriprox Tablets (deferiprone) · Iron chelating agent

Changes in Bevacizumab Labeling

Eculizumab (Soliris)

Drug: Soliris (eculizumab) · Anti-C5 antibody

Denosumab (Prolia)

Drug: Prolia (denosumab) · Anti-RANKL antibody

Crizotinib

Drug: XALKORI Capsules (crizotinib) · ALK inhibitor

Brentuximab Vedotin

Drug: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate

Vemurafenib

Drug: ZELBORAF (vemurafenib) · BRAF inhibitor

Sunitinib

Drug: Sutent Capsules (sunitinib) · VEGFR inhibitor

Everolimus 2011

Drug: Afinitor Tablets (everolimus) · MTOR inhibitor

Abiraterone Acetate

Drug: Zytiga Tablets (abiraterone acetate) · CYP17 inhibitor

Vandetanib

Drug: Vandetanib Tablets (vandetanib) · Multikinase inhibitor

Peginterferon alfa-2b

Drug: Sylatron (peginterferon alfa-2b) · Interferon

Ipilimumab

Drug: YERVOY (ipilimumab) · Anti-CTLA-4 antibody

Rituximab 2011

Drug: Rituxan (rituximab) · Anti-CD20 antibody

Denosumab

Drug: Xgeva (denosumab) · Anti-RANKL antibody

Eribulin Mesylate

Drug: Halaven (eribulin mesylate) · Non-taxane microtubule dynamics inhibitor

Trastuzumab - (Labeling Change)

Everolimus (Accelerated Approval)

Drug: Afinitor (everolimus) · MTOR inhibitor

Dasatinib (Sprycel)

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor

FDA Appoves Trastuzumab (Herceptin)

Drug: Herceptin (trastuzumab) · Anti-HER2 antibody

Gemtuzumab Ozogamicin

Carboplatin dosing

Cabazitaxel

Drug: Jevtana (cabazitaxel) · Taxane

Nilotinib (Tasigna)

Drug: Tasigna Capsules (nilotinib) · Bcr-Abl inhibitor

Hexaminolevulinate Hydrochloride

Drug: Cysview for Intravesical Solution (hexaminolevulinate hydrochloride)

Erlotinib

Drug: Tarceva (erlotinib) · EGFR inhibitor

Rituximab

Drug: Rituxan (rituximab) · Anti-CD20 antibody

FDA approves a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs)"

Tykerb

Drug: Tykerb (lapatinib) · ERBB2 inhibitor

Romidepsin

Drugs: ISTODAX (romidepsin) · HDAC inhibitor, ISTODAX (injection)

Ofatumumab

Drug: Arzerra (ofatumumab) · Anti-CD20 antibody

Pazopanib

Drug: VOTRIENT (pazopanib) · VEGFR inhibitor

Pralatrexate Injection (Folotyn)

Drug: FOLOTYN (pralatrexate) · Antifolate

Bevacizumab (Avastin) in Combination with Interferon Alfa

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, interferon alfa

FDA Approves Cetuximab (Erbitux) and Panitumumab (Vectibix)

Drug: Vectibix Amgen (panitumumab) · Anti-EGFR antibody

Pemetrexed Injection

Drug: Alimta (pemetrexed) · Antifolate

Ferumoxytol (Feraheme) Injection

Bevacizumab Injection

Drug: Avastin (bevacizumab) · Anti-VEGFR antibody

Everolimus

Drug: AFINITOR (everolimus) · MTOR inhibitor

Degarelix

Drug: degarelix · GnRH antagonist

Imatinib Mesylate

Drugs: Gleevec (imatinib mesylate tablets for oral use) · Bcr-Abl inhibitor, Gleevec (oral use)

Plerixafor

Drug: Mozobil (plerixafor) · CXCR4 inhibitor

Eltrombopag

Drug: Promacta (eltrombopag) · Megakaryocyte growth factor

Bendamustine Hydrochloride

Drug: TREANDA (bendamustine hydrochloride) · Nitrogen mustard

Denileukin Diftitox

Drug: Ontak (denileukin diftitox) · Anti-IL-2R immunotoxin

Alimta Injection

Drug: Alimta (pemetrexed) · Antifolate

Iobenguane I 123

Drug: AdreView (iobenguane I 123)

FDA Approves Romiplostim

Drugs: Nplate (romiplostim for subcutaneous) · Megakaryocyte growth factor, Nplate (subcutaneous)

Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma

Drugs: Velcade (bortezomib) · Proteasome inhibitor, Velcade (injection)
Condition: Plasma cell

Bendamustine Hydochloride

Drug: Treanda (bendamustine hydrochloride) · Nitrogen mustard

Bevacizumab Granted Accelerated Approval

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, paclitaxel · Taxane

Sorafenib

Drug: Nexavar (sorafenib) · VEGFR inhibitor

FDA Approves New Boxed Warnings for Epogen, Procrit, and Aranesp

FDA Approves Dasatinib

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor

FDA Approves Nilotinib

Drug: Tasigna Capsules (nilotinib) · Bcr-Abl inhibitor

Ixabepilone

Drugs: Ixempra (ixabepilone) · Non-taxane microtubule dynamics inhibitor, Ixempra (injection)

Cetuximab

FDA Approves Docetaxel

Drug: Taxotere Injection Concentrate (docetaxel) · Taxane

Raloxifene hydrochloride

Drug: EVISTA (raloxifene hydrochloride) · Selective estrogen receptor modulator

Dexrazoxane hydrochloride

Drug: Totect (dexrazoxane hydrochloride) · EDTA derivative

Temsirolimus

Drug: Torisel (temsirolimus) · MTOR inhibitor

FDA Approves Doxorubicin HCl

Drug: Doxil (doxorubicin HCl liposome) · Anthracycline

Erythropoiesis-stimulating Agents (ESAs)

Drugs: Aranesp (darbepoetin alfa) · Erythrocyte growth factor, Epogen (epoetin alfa) · Erythrocyte growth factor

FDA Approves Dalteparin Sodium

Drug: Fragmin (dalteparin sodium) · Low molecular weight heparin

Eculizumab

Lapatinib

Sunitinib malate

Drug: SUTENT (sunitinib malate) · VEGFR inhibitor

FDA approves bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy

Drug: VELCADE (bortezomib) · Proteasome inhibitor
Condition: Lymphoid

FDA Expands the Use of Trastuzumab (Herceptin) for Early Stage Breast Cancer After Primary Therapy

Drug: Herceptin (trastuzumab) · Anti-HER2 antibody
Condition: Breast

FDA approves imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor

FDA approves Taxotere for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck

Drugs: Taxotere Injection Concentrate (docetaxel) · Taxane, cisplatin · Platinum agent, fluorouracil · Fluoropyrimidine
Condition: Head & Neck

FDA approves bevacizumab (Avastin) as a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy

Condition: Thoracic

FDA approves vorinostat (Zolinza) for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL)

Drug: Zolinza (vorinostat) · HDAC inhibitor
Condition: Lymphoid

FDA approves two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves imatinib mesylate (Gleevec) to treat pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves Vectibix (panitumumab) to treat metastatic colorectal carcinoma

Drug: Vectibix (panitumumab) · Anti-EGFR antibody
Condition: Gastrointestinal

FDA approves changes in the Avastin (beacizumab) package insert

Changes in the Neumega Package Insert to Include a Description of Ventricular Arrhythmic and Ophthalmologic Adverse Events

FDA Approves pegaspargase (Oncaspar, Enzon Pharmaceuticals, Inc) for the first-line treatment of patients with acute lymphoblastic leukemia

Drug: Oncaspar (pegaspargase) · Asparagine-specific enzyme
Conditions: LymphoidOther hematologic neoplasm

FDA approves gemcitabine (Gemzar, Eli Lilly and Company)

Drugs: Gemzar (gemcitabine) · Pyrimidine analog, carboplatin · Platinum agent

FDA approves lenalidomide oral capsules (Revlimid) for use in combination with dexamethasone in patients with multiple myeloma

Drug: Revlimid (lenalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA approves dasatinib (Sprycel) for use in the treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase chronic myeloid leukemia

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves a labeling extension for bevacizumab (Avastin, Genentech) for second-line treatment of metastatic carcinoma of the colon or rectum

Condition: Gastrointestinal

FDA approves topotecan hydrochloride (hycamtin) in combination with cisplatin for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix

Drugs: Hycamtin (topotecan hydrochloride) · Topoisomerase I inhibitor, cisplatin · Platinum agent
Condition: Gynecologic

FDA Licenses Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil) for the Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus

Drug: Types 6 (Quadrivalent Human Papillomavirus)
Condition: Gynecologic

FDA Approves Thalomid (thalidomide) to Treat Multiple Myeloma

Drug: Thalomid (thalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA Approves Decitabine for Injection (Dacogen) to Treat Myelodysplastic Syndromes

Drugs: Dacogen (decitabine) · DNA methyltransferase inhibitor, Dacogen (injection)
Condition: Myeloid

Changes in the Ontak (denileukin diftitiox) Package Insert to Include a Description of Ophthalmologic Adverse Events

Erbitux (ceuximab) Approved for Use in Combination with Radiation Therapy

Drug: Erbitux (cetuximab) · Anti-EGFR antibody

FDA approves rituximab (Rituxan) for use in the first‑line treatment of patients with diffuse large B-cell, CD20‑positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline‑based chemotherapy regimens

Drugs: Rituxan (rituximab) · Anti-CD20 antibody, cyclophosphamide · Nitrogen mustard
Condition: Lymphoid

Darbepoetin alfa