European Commission Approves BMS’s Opdivo (Nivolumab)

Bristol-Myers Squibb Company (BMS) has announced that the European Commission has approved Opdivo, a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. This approval allows for the marketing of Opdivo in all 28 Member States of the EU. It follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), which was announced on 24 April 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, and is the first approval given by the European Commission for a PD-1 inhibitor in any cancer.

The incidence of melanoma has continued to increase in almost all European countries, with an estimated one in five patients expected to develop metastatic, or advanced, disease. Historically, prognosis for late-stage metastatic melanoma has been poor: the average survival rate for stage IV is just 6 months with a one-year mortality rate of 75%.

“At BMS, we are continually focused on developing new ways to transform the outlook for patients with some of the hardest-to-treat and deadliest cancers,” said Emmanuel Blin, senior vice president, head of commercialization, policy and operations, BMS. “We are pleased to bring the first PD-1 immune checkpoint inhibitor to the European Union for the treatment of advanced melanoma. We are working relentlessly and at record-breaking speed to build upon our Immuno-Oncology science to deliver new treatment options, with the goal of improving long-term survival for patients.”