Merck Expanded Label for Keytruda Approved

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.