FDA grants nivolumab (Opdivo) its seventh priority review designation.
Bristol-Myers Squibb recently announced that the supplemental biologics license application (sBLA) for nivolumab (Opdivo) was accepted by the FDA for advanced melanoma with a high risk of recurrence after surgery, according to a press release.
Previously, the application for nivolumab was granted breakthrough designation, making it the seventh indication to receive this designation.
The new application was based on positive findings from the phase 3 CheckMate-238 study, which included 906 patients with stage 3b/c or stage 4 melanoma. All patients had received complete resection of the skin cancer, according to the release.
Patients were randomized 1:1 to receive nivolumab intravenously every 2 weeks or ipilimumab (Yervoy) intravenously every 3 weeks for 4 doses and every 12 weeks starting at week 24. Patients received treatment until recurrence, toxicity, or withdrawal up to 1 year.
The primary endpoint was recurrence-free survival and overall survival, with recurrence-free survival by PD-L1 expression, quality of life, and safety as secondary endpoints, according to the release.
The investigators discovered that nivolumab 3-mg/kg met the primary endpoint by reducing disease recurrence compared with ipilimumab 10-mg/kg, according to Bristol-Myers Squibb.
Currently, nivolumab is approved to treat patients with melanoma, non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, and hepatocellular carcinoma, according to the release.
“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.