Opdivo gets PDUFA date for bladder cancer

On Friday, Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted and granted Priority Review to its sBLA for Opdivo nivolumab to treat bladder cancer in a second-line setting. Its PDUFA date is March 2, 2017.

The sBLA covers use of Opdivo in patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing chemotherapy. The PD-1 inhibitor has breakthrough therapy designation in the indication. BMS based its submission on CheckMate -275, a single-arm Phase II study. ...