BioCentury
ARTICLE | Clinical News

BMS' Opdivo gets Priority Review for HCC

August 4, 2017 4:43 PM UTC

In May, FDA accepted and granted Priority Review to an sBLA from Bristol-Myers Squibb Co. (NYSE:BMY) for Opdivo nivolumab (BMS-936558, MDX-1106, ONO-4538) to treat patients with hepatocellular carcinoma (HCC) after prior Nexavar sorafenib therapy. Its PDUFA date is Sept. 24.

The submission was based on the Phase I/II CheckMate -040 trial of Opdivo to treat advanced HCC patients with and without HBV or HCV infections...