ARTICLE | Clinical News

Opdivo nivolumab regulatory update

October 31, 2016 7:00 AM UTC

FDA accepted and granted Priority Review to an sBLA from Bristol-Myers Squibb for Opdivo nivolumab to treat locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy. The PDUFA date is March 2, 2017. The PD-1 inhibitor has breakthrough therapy designation in the indication. BMS based its submission on the Phase II CheckMate -275 trial...