European Ad Comm backs Bristol-Myers' Opdivo for melanoma

• The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Bristol-Myers Squibb's (BMY -0.2%) Opdivo (nivolumab) for both treatment-naive and treatment-experienced patients with advanced (unresectable or metastatic) melanoma. The final decision by the European Commission usually takes ~60 days.
• Opdivo is a PD-1 immune checkpoint inhibitor. PD-1 (programmed cell death protein 1), found on the surface of cancer cells, enables them to avoid detection by the immune system. Binding to PD-1 enables T cells to recognize and kill cancer cells.
• Opdivo was cleared in Japan in July 2014 followed by the U.S. in December for the treatment of melanoma. The FDA approved a label expansion last month for lung cancer.
• Previously: European approval of Bristol-Myers' Opdivo remains elusive (March 27)