Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy with or without bevacizumab for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. This indication is based on KEYNOTE-826 (NCT03635567), a multicenter, randomized, double-blind, placebo-controlled trial where patients received one of the following as the chemotherapy portion of their treatment regimen: cisplatin and paclitaxel; bevacizumab, cisplatin, and paclitaxel; carboplatin and paclitaxel; bevacizumab, carboplatin, and paclitaxel.

This is written in the approval document as:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.

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 (2)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Cisplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Cisplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Carboplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Carboplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab
FDA (2)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals