US regulatory body grants Merck & co’s Keytruda priority review
FDA has accepted Merck & Co’s anti-PD-1 therapy, Keytruda, in combination with Eli Lilly’s pemetrexed and platinum chemotherapy as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The regulators has also granted Priority Review to this application.
This supplemental application is based on overall survival and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial. KEYNOTE-189 is the confirmatory trial for KEYNOTE-021 (Cohort G), a Phase 2 study that made Keytruda the only FDA-approved anti-PD-1 therapy in combination with chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression.
If approved by the FDA, this would mark the third indication for Keytruda in metastatic NSCLC in the United States based on overall survival data.