FDA Oncology Announcements

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79 Announcements

2026-02-26

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

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

2025-11-19

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

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

2025-11-19

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

2025-10-02

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

2025-08-08

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

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

2025-07-02

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

2025-06-23

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

2025-06-11

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

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

2025-05-14

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

2024-12-18

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

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

2024-12-04

FDA approves durvalumab for limited-stage small cell lung cancer

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

2024-12-04

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

2024-10-03

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

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

2024-09-25

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

2024-09-19

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

2024-09-17

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

2024-08-19

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

2024-08-15

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

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

2024-06-13

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

2024-05-16

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

2024-04-18

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

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

2024-04-05

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

2024-03-01

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

2024-02-16

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

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

2024-02-15

FDA approves tepotinib for metastatic non-small cell lung cancer

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

2023-11-15

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

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

2023-10-16

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

2023-10-11

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

2023-08-09

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

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

2023-01-26

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

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

2022-12-12

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

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

2022-11-10

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

2022-11-08

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

2022-09-21

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

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

2022-09-21

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

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

2022-09-20

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

2022-08-11

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

2022-08-10

FDA approves capmatinib for metastatic non-small cell lung cancer

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

2022-06-22

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

2022-03-04

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

2021-10-15

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

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

2021-09-15

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

2021-08-18

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

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

2021-05-28

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

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

2021-05-21

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

2021-03-03

FDA approves lorlatinib for metastatic ALK-positive NSCLC

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

2021-02-22

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

2021-02-03

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

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

2020-12-18

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

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

2020-10-26

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

2020-10-02

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

2020-09-04

FDA approves pralsetinib for lung cancer with RET gene fusions

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

2020-06-16

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

2020-06-15

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

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

2020-05-29

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

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

2020-05-26

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

2020-05-22

FDA approves brigatinib for ALK-positive metastatic NSCLC

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

2020-05-18

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

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

2020-05-15

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

2020-05-06

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

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

2020-03-30

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

2019-12-03

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

2019-08-15

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

2019-06-17

FDA approves pembrolizumab for metastatic small cell lung cancer

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

2019-04-11

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

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

2019-03-18

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