EU Approves BMS’ Opdivo for Advanced Melanoma

The European Commission has approved Bristol-Myers Squibb’s Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. The approval allows for the marketing of Opdivo in all 28 European Union member states. It follows an accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use, which was announced on April 24, 2015. 

In the US, Opdivo is approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. In March 2015, Opdivo received its second US Food and Drug Administration approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Opdivo was first approved in Japan in July 2014 for treating unresectable melanoma.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials, as a monotherapy or in combination with other therapies , in which more than 7,000 patients have been enrolled worldwide.

In 2011, through a collaboration agreement with Ono Pharmaceutical, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. In July 2014, Bristol-Myers Squibb and Ono Pharmaceutical further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens in Japan, South Korea, and Taiwan.

Source: Bristol-Myers Squibb

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