Regulatory approval

Published by the European Medicines Agency. Approved

KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS >= 1.

This is written in the approval document.

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Carboplatin, Fluorouracil, Pembrolizumab
EMA (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Pembrolizumab