Bristol+Myers+Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.
U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb's Application for Opdivo (nivolumab) Plus Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer
Feb 28, 2022
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