Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to 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.

This is written in the approval document as:

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.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s178lbl.pdf. Revised July 2025. Accessed September 2, 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	Head and Neck Squamous Cell Carcinoma	Pembrolizumab