Bristol-Myers Squibb: FDA Accepts SBLA For Opdivo; Grants Priority Review

(RTTNews) - Bristol-Myers Squibb Company (BMY) announced the U.S. FDA has accepted for filing and review the sBLA for Opdivo for the treatment of previously treated patients with non-squamous non-small cell lung cancer. The sBLA seeks to expand the current indication for Opdivo in patients with previously treated squamous non-small cell lung cancer. The submission is based on CheckMate -057, a Phase 3 study.

FDA has also granted the company's application priority review, and Opdivo Breakthrough Therapy Designation for this indication. The projected FDA action date is January 2, 2016.