On April 30, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) based on results of the phase III KEYNOTE-189 trial. The application seeks approval for pembrolizumab in combination with pemetrexed (Alimta) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC). The FDA has granted Priority Review to this sBLA, and has set a Prescription Drug User Fee Act date of September 23, 2018.
This supplemental application is based on overall survival (OS) and progression-free survival (PFS) data from the KEYNOTE-189 trial, which were recently presented at the 2018 American Association of Cancer Research Annual Meeting (Abstract CT075) and published simultaneously by Gandhi et al in The New England Journal of Medicine. KEYNOTE-189 is the confirmatory trial for KEYNOTE-021 (Cohort G), a phase II study that contributed to the FDA approval of anti–programmed cell death protein 1 (PD-1) therapy in combination with chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic nonsquamous NSCLC, regardless of programmed cell death ligand 1 (PD-L1) expression. If approved by the FDA, this would mark the third indication for pembrolizumab in metastatic NSCLC in the United States based on OS data.
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