Japan approves Opdivo for gastric cancer

Bristol-Myers Squibb Co. (NYSE:BMY) said Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Opdivo nivolumab (BMS-936558, MDX-1106, ONO-4538) in September to treat unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy.

The Japan approval was based on data from the Phase III ATTRACTION-2 trial, in which Opdivo significantly reduced the risk of death by 37% vs. placebo in the indication. The human IgG4 mAb against PD-1 is approved in more than 60 countries, including the U.S. and EU, for various cancer indications. BMS said Opdivo is now approved for 6 indications in Japan...