Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. This indication is based on KEYNOTE-189 (NCT02578680), a randomized, multicenter, double-blind, active-controlled trial conducted in 616 patients where the choice of platinum-containing chemotherapy was either carboplatin or cisplatin.

This is written in the approval document as:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Pembrolizumab, Pemetrexed
FDA (2)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Pembrolizumab, Pemetrexed

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-08-20	Food and Drug Administration	Indication received traditional approval.