Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung carcinoma whose tumors express PD-L1 with a >= 1% tumor proportion score (TPS) and who have recieved at least one prior chemotherapy regime. Patients with EGFR or ALK positive tumor mutations should also have received targeted therapy before receiving pembrolizumab.

This is written in the approval document as:

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.

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 >= 1%	Non-Small Cell Lung Cancer	Pembrolizumab