Posted by Michael Wonder on 31 Jan 2019
FDA expands Lilly's Alimta (pemetrexed) label with combination of Keytruda (pembrolizumab) and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer
31 January 2019 - New approval based on Phase 3 KEYNOTE-189 results.
Eli Lilly today announced that the U.S. FDA has granted approval for a new indication for Alimta (pemetrexed for injection) in combination with Keytruda (pembrolizumab), developed and marketed by Merck, and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
This indication is approved based on data from Merck's Phase 3 KEYNOTE-189 trial, which enrolled patients regardless of PD-L1 expression and had dual primary endpoints of overall survival and progression-free survival.
