Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma in adult patients whose tumors express PD-L1 with a >= 50% tumor proportion score (TPS) with no EGFR or ALK positive tumor mutations.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
Sensitivity (+)	CD274 amplification, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab