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Bristol-Myers Squibb's biologics licensing application for Opdivo accepted for filing and review by US FDA
3 March 2015 - United States-based Bristol-Myers Squibb's biologics licensing application for Opdivo (nivolumab) has been accepted for filing and review by the United States Food and Drug Administration, it was reported yesterday.

The product is used to treat patients with advanced squamous non-small cell lung cancer after prior therapy. The agency also granted priority review for this biologics licensing application and has given the Prescription Drug User Fee Act goal date of 22 June 2015, for a decision.

The FDA acceptance is based on data from CheckMate -063, a Phase II single arm, open-label trial designed to assess advanced squamous non-small cell lung cancer patients who progressed after both platinum-based therapy and at least one additional systemic therapy.

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