FDA Oncology Announcements

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52 Announcements

2026-02-10

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

2025-09-19

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
Condition: Other solid neoplasm

2025-05-08

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

2024-08-01

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

2024-06-17

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

2024-06-14

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

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

2024-04-29

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

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

2024-03-22

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

2024-01-12

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

2023-10-20

FDA expands pediatric indication for entrectinib and approves new pellet formulation

Trial: STARTRK-NG
Drug: Rozlytrek (entrectinib) · TRK inhibitor
Condition: Other solid neoplasm

2023-07-31

FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer

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

2023-02-09

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

2022-11-14

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

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

2022-06-22

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

2022-03-21

FDA approves pembrolizumab for advanced endometrial carcinoma

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

2021-11-29

FDA approves pafolacianine for identifying malignant ovarian cancer lesions

Drug: Cytalux (pafolacianine)
Condition: Gynecologic

2021-10-13

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

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

2021-09-20

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

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

2021-07-21

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

2021-04-22

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

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

2020-10-26

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

Conditions: BreastGynecologicThoracic

2020-10-26

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

2020-10-26

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

2020-06-16

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

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

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

2020-05-08

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

2020-05-08

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

2020-04-29

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

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

2020-04-29

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

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

2019-10-23

FDA approves niraparib for HRD-positive advanced ovarian cancer

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

2019-09-17

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

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

2018-12-19

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

2018-11-26

FDA approves larotrectinib for solid tumors with NTRK gene fusions

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

2018-06-13

FDA approves bevacizumab in combination with chemotherapy for ovarian cancer

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

2018-06-12

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

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

2018-04-06

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

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

2017-11-30

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic

Conditions: BreastDermatologicGastrointestinalGynecologicThoracic

2017-08-17

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

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

2016-12-19

Rucaparib

Drug: RUBRACA (rucaparib) · PARP inhibitor
Condition: Gynecologic

2014-12-19

Olaparib

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

2014-08-14

Bevacizumab solution

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

2013-10-08