Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test.

This is written in the approval document as:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy 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/2025/125514s174lbl.pdf. Revised April 2025. Accessed April 30, 2025.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Pembrolizumab