Keytruda (pembrolizumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

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 October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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