European Commission approves Bristol-Myers Squibb's Opdivo

The European Commission has approved US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status, the company revealed on Friday.

The approval allows for the marketing of Opdivo in all 28 member states of the European Union and follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), which was announced on April 24, 2015. This accelerated assessment was given because Opdivo qualified for the designation as a “medicinal product of major interest from the point of view of public health and in particular from the view point of therapeutic innovation.” Opdivo is the only PD-1 immune checkpoint inhibitor to receive an accelerated assessment in Europe, andis the first approval given by the European Commission for a PD-1 inhibitor in any cancer.

Melanoma market forecasts and Opdivo prospects