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# Merck sNDA for 1st Line Keytruda in Lung Cancer Approved
- URL: https://www.fdaweb.com/merck-snda-for-1st-line-keytruda-in-lung-cancer-approved/
- Published: 2016-10-25T12:00:00.000Z
- Updated: 2026-09-14T21:42:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137170

FDA has approved a Merck supplemental NDA for Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score of 50% or more) as determined by an agency-approved test, with no EGFR or ALK genomic tumor aberrations. In addition, FDA approved a labeling update to include data from the KEYNOTE-010 clinical trial in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1, with disease progression on or after platinum-containing chemotherapy, according to the company. “Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda,” it says.

Approval was based on data from KEYNOTE-024, which demonstrated that Keytruda reduced the risk of disease progression or death by 50% compared to chemotherapy, Merck says. Additionally, the therapy resulted in a 40% reduction in the risk of death compared to chemotherapy.