EMA Recommends Authorization of Melanoma Treatment

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The agency has recommended granting marketing authorization for Opdivo.


The European Medicines Agency (EMA) announced on April 24, 2015 that the agency has recommended marketing authorization for Bristol-Myers Squibb’s (BMS) monoclonal antibody (mAb) Opdivo (nivolumab) for the treatment of advanced melanoma in adults. Opdivo is a “programed death-1” (PD-1) immune checkpoint inhibitor that activates the immune system to fight melanoma cells.

EMA based the recommendation on two studies of patients with advanced malignant melanoma. In one study, 418 patients who had not received previous treatment received either Opdivo or standard chemotherapy (dacarbazine). The Opdivo patients had a higher survival rate after 12 months than the patients who received the standard treatment (73% compared with 42%). The second study gave Opdivo to 405 random patients who had been previously treated for their melanoma. The study found that a greater percentage of patients responded to Opdivo compared with chemotherapy (31.7% compared with 10.6%). The Committee for Medicinal Products for Human Use (CHMP) has agreed on a follow-up plan to monitor the safety and efficacy of Opdivo.


“We are pleased with today’s positive opinion, as it is a step closer to us bringing this important medicine for those advanced melanoma patients in Europe in need of new options,” said Michael Giordano, BMS senior vice-president, head of development, Oncology, in a press release. “Our vision is to transform how we approach cancer-from clinical practice to improved patient outcomes. We continue to expand the breadth and depth of our immuno-oncology portfolio across the continuum of melanoma and multiple other cancers, to provide more patients with the potential opportunity for long-term survival.”

Sources: EMA; Bristol-Myers Squibb