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24 Oct 2017

Case Study: US FDA priority review grants for BMS’s sBLA for Opdivo to treat patients with resected high-risk advanced melanoma

Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) 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, which is the seventh indication for which Opdivo has received this designation.

The application is based on data from the ongoing Phase 3 CheckMate -238 study, which evaluated Opdivo in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. In the study, Opdivo 3 mg/kg met the primary endpoint by significantly decreasing the risk of disease recurrence compared to Yervoy (ipilimumab) 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.

KPE-C-003 KPE’s Advance Diploma in Drug Regulatory Affairs

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