FDA, EMA reviewing Opdivo for head/neck cancer

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA and EMA accepted marketing applications for Opdivo nivolumab to treat relapsed squamous cell carcinoma of the head and neck (SCCHN). FDA granted Priority Review to an sBLA for the drug, which has a Nov. 11 PDUFA date.

In April, BMS said Opdivo improved overall survival compared with standard of care in the Phase III CheckMate -141 study to treat SCCHN (see BioCentury Extra, April 19). ...