FDA Grants Priority Review to Adjuvant Nivolumab in Melanoma

October 18, 2017 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for nivolumab 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 … (leggi tutto)