BioCentury
ARTICLE | Company News

Opdivo gets Priority Review for non-squamous NSCLC

September 3, 2015 12:42 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted for filing and granted Priority Review to an sBLA for Opdivo nivolumab to treat non-squamous non-small cell lung cancer (NSCLC) in previously treated patients. The PDUFA date is Jan. 2.

BMS also said FDA granted breakthrough therapy designation to the human IgG4 mAb against PD-1 for the indication. The sBLA submission is based on data from the Phase III CheckMate -057 trial (see BioCentury Extra, May 29). ...