Bristol-Myers Squibb Company has announced that 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.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, commented, “Squamous cell carcinoma of the head and neck that progresses after platinum therapy is a devastating disease with a poor prognosis and has had very few treatment advancements in nearly a decade. Based on findings from CheckMate -141, Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit in a Phase 3 trial in these patients. These milestones are important steps in the regulatory processes, and we look forward to working with authorities in the U.S. and Europe to offer Opdivo to this patient population.”
Both U.S. and European submissions were based on CheckMate -141, a pivotal Phase 3 open-label, randomized trial, that evaluated the overall survival (OS) of Opdivo in patients with SCCHN after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab). Based on a planned interim analysis, this trial was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded the study met its primary endpoint of OS in patients receiving Opdivo compared to investigator’s choice of therapy. Overall survival results from CheckMate -141 were first presented at the 2016 Annual Meeting of the American Association for Cancer Research.