U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ...
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
First-ever application for an I-O/I-O combination in lung cancer to be accepted Submission based on positive results from Part 1 of the Phase 3 study CheckMate -227 PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) =10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 2019. Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, “Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients.
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