PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today U.S. and European marketing applications to expand the use of Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were accepted for filing by the U.S. Food and Drug Administration (FDA) and validated by the European Medicines Agency (EMA). In the U.S., the FDA accepted the Company’s supplemental Biologics License Application (sBLA) for Opdivo in SCCHN with priority review, and previously granted the agent Breakthrough Therapy Designation in April 2016. The projected FDA action date is November 11, 2016. In Europe, the EMA validated a type II variation application for the same patient population. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
