Bristol applications for Opdivo + Yervoy new use accepted in U.S. and Europe

The FDA and EMA (European Medicines Agency) have accepted for review Bristol-Myers Squibb’s (NYSE:BMY) supplemental marketing applications seeking approval to use the combination of Opdivo (nivolumab) and Yervoy (ipilimumab), together with limited chemo, for the first-line treatment of patients with recurrent/metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK mutations.

The FDA’s action date is August 6.

The company’s partner in Japan, Ono Pharmaceutical Co., filed a marketing application there about two weeks ago.

https://seekingalpha.com/news/3559226-bristol-myers-squibb-applications-for-new-use-of-o-y-accepted-in-u-s-and-europe