Bristol-Myers Squibb (BMY) announced that the FDA and the European Medicines Agency (EMA) have accepted for review its market applications seeking approval of Opdivo (nivolumab) for the treatment of patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The FDA's action date (PDUFA) is November 11. The EMA's centralized review process is underway. The data supporting both filings were generated in the Phase 3 Checkmate-141 study that showed SCCHN patients treated with Opdivo after platinum-based chemo experienced a statistically valid increase in overall survival compared to those receiving investigator's choice of therapy. The study was stopped early after the independent Data Monitoring Committee determined that the study met its primary endpoint.