Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-small cell lung carcinoma in adult patients whose tumors have no EGFR or ALK positive mutations. This indication is based on results from KEYNOTE-024, where patients received pembrolizumab in combination with investigator's choice of platinum-containing chemotherapy, including: pemetrexed with carboplatin, pemetrexed with cisplatin, gemcitabine and cisplatin, gemcitabine and carboplatin, or paclitaxel and carboplatin.

This is written in the approval document as:

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive 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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Pembrolizumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Pembrolizumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Pembrolizumab
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Gemcitabine, Pembrolizumab
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Paclitaxel, Pembrolizumab