Bristol-Myers Squibb Reveals Regulatory Approvals for Its Opdivo Marketing Application

Bristol-Myers Squibb Company

disclosed that the FDA and the European Medicines Agency have accepted their marketing applications to expand Opdivo use for patients with the previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Bristol-Myers said that the FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo in SCCHN with priority review in the United States, and previously granted the agent Breakthrough Therapy Designation in April. The company expects the regulator to take action by November 11. As far as Europe, the company indicated that EMA validated a type II variation application for the same patient population. As a result, validation of the application confirmed that the submission is complete and centralized review process started. The company's Global Clinical Research Lead, Jean Viallet, 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 Opdivoto this patient population." Bristol-Myer said that both the submissions were based on CheckMate -141, a pivotal Phase 3 open-label, randomized trial, which assessed the overall survival (OS) of Opdivo in patients with SCCHN after platinum therapy compared to investigator's choice of therapy (methotrexate, docetaxel, or cetuximab). On Friday, the stock shed 1.00 percent.