Regulatory approval

Published by the Food and Drug Administration. Approved

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >= 1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT), with or without cisplatin and then as a single agent.

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 (2)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Pembrolizumab

Contributions

Date	Contributor	Description
2025-09-02	Van Allen lab	On June 12th, 2025, the US FDA approved pembrolizumab as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin, and then as a single agent for the treatment of adult patients with resectable locally advanced head and neck squamous cell cancer (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) >= 1], as determined by an FDA-approved test.
2025-06-12	Food and Drug Administration	Indication received traditional approval.