FDA approves expanded label for Merck's Keytruda, Alimta combination
Merck announced that the U.S. Food and Drug Administration has approved an expanded label for KEYTRUDA, Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial. In the pivotal, Phase 3 KEYNOTE-189 trial of patients regardless of PD-L1 tumor expression status, KEYTRUDA in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival, 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. Data from KEYNOTE-189 support that KEYTRUDA is changing survival expectations for these patients. "KEYTRUDA is rapidly becoming a foundation for the treatment of appropriate patients with metastatic non-small cell lung cancer," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "Today's approval of the expanded label for KEYTRUDA based on data from the KEYNOTE-189 trial is an important milestone, and reinforces our steadfast commitment to improving survival outcomes, and providing hope, for more patients with lung cancer."