Opdivo (nivolumab) filed at FDA for treatment of NSCLC- BMS
Bristol-Myers Squibb announced that the FDA has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is 22 June 2015. The filing acceptance is based on submission of clinical data from CheckMate-063, a Phase II single arm, open-label study designed to assess advanced squamous NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy.
Comment: the EMA validated the MAA for Opdivo in NSCLC for review in September 2014.
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