Bristol-Myers says FDA and EMA accept filing for expanded Opdivo indications

US pharma major Bristol-Myers Squibb (NYSE: BMY) today announced that both the US Food and Drug Administration and European Medicines Agency have accepted marketing applications to expand the use of Opdivo (nivolumab) for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

These regulatory submissions were based on CheckMate -141, in which Opdivo met its primary endpoint of overall survival in patients with SCCHN after platinum therapy compared to investigator’s choice of therapy.

In the USA, the FDA accepted the company’s supplemental Biologics License Application (sBLA) 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, which begins the EMA’s centralized review process. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.