FDA Approves Nivolumab for Advanced Melanoma
Tuesday, December 23, 2014
The FDA has approved the PD-1 inhibitor nivolumab (Opdivo) for patients with unresectable or metastatic melanoma following treatment with ipilimumab or a BRAF inhibitor, based on data from the phase III CheckMate-037 trial.
In the study, the fully human IgG4 monoclonal antibody nivolumab demonstrated an overall response rate (ORR) of 32% compared with 11% in patients treated with chemotherapy. At the 6-month analysis, 95% of responses were ongoing, with a median duration of response not yet reached. Additionally, fewer serious adverse events were reported with nivolumab compared with chemotherapy.
The deadline for the FDA's decision on nivolumab was scheduled for March 30, 2015. The accelerated approval was granted under the FDA's breakthrough therapy and priority review designations. Nivolumab is the second PD-1 inhibitor to gain approval in 2014.