ARTICLE | Clinical News

Opdivo nivolumab regulatory update

July 25, 2016 7:00 AM UTC

Bristol-Myers Squibb said FDA and EMA accepted for review regulatory submissions for Opdivo nivolumab to treat previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). FDA granted Priority Review to an sBLA for the drug; the PDUFA date is Nov. 11. Both submissions are based on the international Phase III CheckMate -141 trial, which was stopped early in January after an analysis by an IDMC showed that Opdivo met the primary endpoint (see BioCentury, Feb. 1). ...