FDA Oncology Announcements

Gynecologic × Clear all

37 Announcements

2026-03-25

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

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

2025-05-08

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

2023-07-31

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