Jedd D. Wolchok, MD, PhD
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.
... to read the full story