Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
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