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# Merck’s Keytruda Gains Added Monotherapy Use
- URL: https://www.fdaweb.com/mercks-keytruda-gains-added-monotherapy-use/
- Published: 2019-04-12T12:00:00.000Z
- Updated: 2026-09-15T01:20:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143854

FDA has [approved an expanded label](https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-expanded-monotherapy-label-mercks-keytruda-pemb?ref=fdaweb.com) for Merck’s Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with Stage 3 non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Approval was based on data from the Phase 3 KEYNOTE-042 trial, in which monotherapy demonstrated a statistically significant improvement in overall survival compared with chemotherapy alone in patients whose tumors expressed PD-L1.