Regulatory approval

Published by the European Medicines Agency. Approved

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.

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 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
EMA (1)	CD274 amplification, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2017-01-27	European Medicines Agency	Indication received approval from the European Commission.