Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Pembrolizumab in patients with Head and Neck Squamous Cell Carcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026. Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s180lbl.pdf. Revised June 2025. Accessed October 6, 2026.

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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.