The FDA approves Bristol-Myers Squibb's (BMY -0.4%) PD-1 inhibitor Opdivo (nivolumab) for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. Opdivo's intended use is for patients who have been previously treated with ipilimumab (Yervoy) or ipilimumab plus a BRAF inhibitor if mutation positive. This is a good example of the benefits of the Fast Track designation. The PDUFA date was March 30, 2015.
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