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

Jason M. Broderick @jasoncology
Published: Saturday, Jan 23, 2016

Dr. Jedd D. Wolchok

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.

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