Categorized | Melanoma News, Regulatory

FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma

Source: The ASCO Post, October 2017

On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its 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. The FDA also previously granted Breakthrough Therapy Designation for this application.
“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,” said Murdo Gordon, Executive Vice President and Chief Commercial Officer, Bristol-Myers Squibb.
The application is based on data from the ongoing phase III CheckMate-238 study, which evaluated nivolumab in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. In the study, nivolumab 3 mg/kg met the primary endpoint by significantly decreasing the risk of disease recurrence compared to ipilimumab (Yervoy) 10 mg/kg, an FDA-approved treatment for stage III adjuvant melanoma. The results of the study were recently presented at the European Society for Medical Oncology (ESMO) 2017 Congress and published simultaneously in The New England Journal of Medicine.
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