Categorized | Melanoma News, Regulatory

FDA grants priority review to Opdivo for resected, high-risk melanoma

Source: Healio, October 2017

The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.
Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, previously received breakthrough therapy designation for this indication.
“Priority review of our supplemental biologics license application and the granting of breakthrough designation are positive steps forward in our goal to address the high unmet need that exists among patients with resected advanced melanoma, many of whom experience disease recurrence,” Murdo Gordon, executive vice president and chief commercial officer at Bristol-Myers Squibb, said in a company-issued release.
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