Regulatory approval

Published by the Health Canada.

Health Canada approved Pembrolizumab for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1), as neoadjuvant treatment as monotherapy, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as monotherapy.

This is written in the approval document as:

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1), as determined by a validated test, as neoadjuvant treatment as monotherapy, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as monotherapy.

Citation

Merck Canada Inc. Keytruda (pembrolizumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083378.PDF. Published January 2026. Accessed April 2026.

Therapeutic response

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

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
HC (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Cisplatin, Paclitaxel, Pembrolizumab
HC (1)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab
HC (1)	PD-L1 (CPS) >= 1	Cervical Squamous Cell Carcinoma	Bevacizumab, Carboplatin, Paclitaxel, Pembrolizumab