Regulatory approval

Published by the Food and Drug Administration. Approved

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) PD-L1 (CPS) >= 1 Head and Neck Squamous Cell Carcinoma Pembrolizumab