Categorized | Melanoma News, Regulatory

FDA Grants Priority Review to Adjuvant Nivolumab in Melanoma

Source: OncLive, October 2017

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.
Previously, the FDA granted a breakthrough designation for nivolumab in this setting. The priority review is based on results from the CheckMate-238 trial, in which nivolumab significantly improved relapse-free survival (RFS) versus standard ipilimumab (Yervoy) in patients with resected stage IIIB/C and IV melanoma.
“Priority review of our sBLA 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, BMS executive vice president and chief commercial officer, said in a press release.
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