Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >= 1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
This is written in the approval document as:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >= 1) as determined by an FDA-authorized test, and who have recieved one or two prior systemic treatment regimens.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organization(s) | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| FDA (1) | PD-L1 (CPS) >= 1 | Ovarian Epithelial Tumor | Paclitaxel, Pembrolizumab | |
| FDA (1) | PD-L1 (CPS) >= 1 | Ovarian Epithelial Tumor | Bevacizumab, Paclitaxel, Pembrolizumab | |
| FDA (1) | PD-L1 (CPS) >= 1 | High-Grade Serous Fallopian Tube Cancer | Paclitaxel, Pembrolizumab | |
| FDA (1) | PD-L1 (CPS) >= 1 | High-Grade Serous Fallopian Tube Cancer | Bevacizumab, Paclitaxel, Pembrolizumab | |
| FDA (1) | PD-L1 (CPS) >= 1 | Peritoneal Serous Carcinoma | Paclitaxel, Pembrolizumab | |
| FDA (1) | PD-L1 (CPS) >= 1 | Peritoneal Serous Carcinoma | Bevacizumab, Paclitaxel, Pembrolizumab |