Current Edition

FDA grants Keytruda priority review

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The FDA has accepted for review Merck & Co’s anti-PD-1 therapy Keytruda in combination with Eli Lilly’s Alimta (pemetrexed) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The Association has also granted Priority Review to this application.
This supplemental application is based on overall survival (OS) 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 OS data.