FDA approves Opdivo for head and neck cancer

FDA approved an sBLA from Bristol-Myers Squibb Co. (NYSE:BMY) for Opdivo nivolumab to treat recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.

The agency said it based the approval on data from the Phase III CheckMate -141 trial, in which Opdivo significantly improved overall survival compared with standard of care (see BioCentury Extra, April 19)...