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# Merck Expanded Label for Keytruda Approved
- URL: https://www.fdaweb.com/merck-expanded-label-for-keytruda-approved/
- Published: 2018-08-20T12:00:00.000Z
- Updated: 2026-09-15T00:27:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142154

FDA has approved a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. The approval was based on results of the KEYNOTE-189 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival, and reducing the risk of death by half compared to chemotherapy alone. The study also showed a significant improvement in progression-free survival compared to chemotherapy alone. Keytruda in combination with pemetrexed and carboplatin was first approved in 2017 under the agency’s accelerated approval process for first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and progression-free survival data.