FDA accepts Bristol-Myers sBLA on Opdivo for priority review

The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) from pharma major Bristol-Myers Squibb (NYSEL BMY), which seeks to expand the use of Opdivo (nivolumab) to patients with classical Hodgkin lymphoma (cHL) after prior therapies.

The European Medicines Agency recently validated the company’s application to extend the use of Opdivo for this indication (The Pharma Letter April 1).

The application included CheckMate -205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. The FDA granted the application a priority review and previously granted Opdivo Breakthrough Therapy Designation for cHL on May 14, 2014. According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.