FDA Expands Nivolumab’s Frontline Melanoma Approval to Include BRAF-Mutant Patients

Source: OncLive, January 2016

The FDA has expanded the frontline melanoma indications for nivolumab (Opdivo) as a single agent and in combination with ipilimumab (Yervoy) to include patients with BRAF V600 mutations, based on data from the phase III CheckMate-067 trial.

Nivolumab was previously approved in advanced melanoma as a monotherapy and in combination with ipilimumab for BRAF V600 wild-type patients, as well as for patients with unresectable or metastatic melanoma following treatment with ipilimumab or a BRAF inhibitor. The new indications for patients with BRAF mutations are both accelerated approvals that are contingent on results from confirmatory trials.

In the three-arm CheckMate-067 study, the combination of nivolumab and ipilimumab reduced the risk of progression by 58% compared with ipilimumab alone (HR, 0.42; P <.0001) in patients with advanced melanoma. Single-agent nivolumab reduced the risk of progression by 43% versus ipilimumab (HR, 0.57; P <.0001). Outcomes were similar regardless of BRAF mutation status.