FDA Oncology Announcements

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258 Announcements

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

FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection

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

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

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

FDA approves new interchangeable biosimilar to Perjeta

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

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 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)

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

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 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 updated drug labeling for fludarabine phosphate under Project Renewal

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

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

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

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

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

FDA expands pediatric indication for entrectinib and approves new pellet formulation

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

FDA approves new and updated indications for temozolomide under Project Renewal

Drug: Temodar (temozolomide) · Triazene

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

Drug: Omisirge (omidubicel-onlv)

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

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

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

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 approves alpelisib for PIK3CA-related overgrowth spectrum

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

FDA approves abatacept for prophylaxis of acute graft versus host disease

Drug: Orencia (abatacept)
Condition: Other

FDA approves rituximab plus chemotherapy for pediatric cancer indications

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

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

FDA approves ruxolitinib for chronic graft-versus-host disease

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

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

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

FDA approves belumosudil for chronic graft-versus-host disease

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

FDA approves new dosing regimen for cetuximab

Drug: Erbitux (cetuximab) · Anti-EGFR antibody

FDA approves device for treatment of osteoid osteoma in the extremities

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

FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

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

Drug: KOSELUGO (selumetinib) · MEK inhibitor

FDA approves voxelotor for sickle cell disease

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

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 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

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 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 new formulation of Herceptin for subcutaneous use

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

FDA approved caplacizumab-yhdp

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

FDA approves longer-acting calaspargase pegol-mknl for ALL

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

FDA approves Herzuma as a biosimilar to Herceptin

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

FDA approves romiplostim for pediatric patients with immune thrombocytopenia

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

Atezolizumab (TECENTRIQ)

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

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 updates prescribing information for Keytruda and Tecentriq

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 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 fostamatinib tablets for ITP

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

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)

Brentuximab Vedotin

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

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

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

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 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 first biosimilar for cancer treatment

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

FDA expands ibrutinib indications to chronic GVHD

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

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 accelerated approval to pembrolizumab for first tissue/site agnostic indication

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

Pembrolizumab (Keytruda) 5-10-2017

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

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)

Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor

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

Olaratumab (LARTRUVO)

Drug: LARTRUVO (olaratumab) · Anti-PDGFR antibody

Atezolizumab (TECENTRIQ)

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

Erlotinib (Tarceva)

Drug: TARCEVA (erlotinib) · EGFR inhibitor

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)

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

Trametinib/Dabrafenib

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

Ixazomib

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

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

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

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

FDA grants accelerated approval to Ibrutinib (Imbruvica)

Drug: IMBRUVICA (Ibrutinib) · BTK inhibitor

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)

FDA Approves Trametinib

Drug: MEKINIST tablet (trametinib) · MEK inhibitor

Dabrafenib

Drug: TAFINLAR capsule (dabrafenib) · BRAF 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

Everolimus 2012

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

Carfilzomib

Drug: Kyprolis (carfilzomib) · Proteasome inhibitor

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

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

Nilotinib (Tasigna)

Drug: Tasigna Capsules (nilotinib) · Bcr-Abl inhibitor

Cabazitaxel

Drug: Jevtana (cabazitaxel) · Taxane

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)

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 imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor

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 gemcitabine (Gemzar, Eli Lilly and Company)

Drugs: Gemzar (gemcitabine) · Pyrimidine analog, carboplatin · Platinum agent

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

Darbepoetin alfa