FDA Oncology Announcements

Anti-PD-1 × Gynecologic × Clear all

16 Announcements

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

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

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 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 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 dostarlimab-gxly with chemotherapy for endometrial cancer

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

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 pembrolizumab for advanced endometrial carcinoma

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

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

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

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 grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

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

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 pembrolizumab for adults and children with TMB-H solid tumors

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

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

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

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