Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of adult patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 1.

This is written in the approval document as:

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-11-14	European Medicines Agency	Indication received approval from the European Commission.