Bristol-Myers Squibb updates on Opdivo regulatory milestones

US pharma major Bristol-Myers Squibb (NYSE:BMY) has announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the USA and European Union.

In the USA, the Food and Drug Administration has accepted for priority review the Biologics License Application for previously treated advanced melanoma and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is March 30, 2015. The FDA also granted Opdivo Breakthrough Therapy status for this indication.

In the European Union, the European Medicines Agency has validated for review the Marketing Authorization Application for Opdivo in advanced melanoma. The application has also been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).