The U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.

This approval expanded the original indication for the immunotherapy combination for the treatment of BRAF wild-type unresectable or metastatic melanoma to include patients with BRAF mutation-positive disease.1

The FDA also expanded the use of single-agent nivolumab to include treatment-naïve patients with BRAF­ mutation-positive advanced melanoma. It was previously approved for only those with BRAF V600 wild-type disease.

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“For nearly a decade, our researchers have worked tirelessly to find treatment options that could improve outcomes for patients with late-stage melanoma, a particularly aggressive cancer, and we are incredibly proud of today’s approval to expand the use of the Opdivo + Yervoy Regimen to include patients with BRAF mutation-positive unresectable or metastatic melanoma,” said Chris Boerner, Head of US Commercial, Bristol-Myers Squibb.

Approval is based on findings from the phase 3 CheckMate-067 trial. The study demonstrated a statistically significant improvement in progression-free survival in both patients with BRAF V600 mutant and wild-type advanced melanoma treated with nivolumab and ipilimumab and with single-agent nivolumab compared with ipilimumab alone. Both treatments also resulted in higher confirmed objective response rates than ipilimumab monotherapy.

In the study, serious adverse reactions, adverse reactions resulting in treatment discontinuation or dosing delays, and grade 3 or 4 adverse events were all more common in the combination arm compared with nivolumab alone. The most common adverse events with the immunotherapy combination were fatigue, rash, diarrhea, nausea, pyrexia, vomiting, and dyspnea.

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“CheckMate-067 is the first phase 3 study to observe the efficacy and safety of both Opdivo as a single-agent as well as in combination with Yervoy versus Yervoy alone,” Boerner said.

“The melanoma community is excited to see the ongoing developments in research from the pharmaceutical industry, including Bristol-Myers Squibb, who made the first approved combination of 2 immuno-oncology treatments available to more patients fighting this disease,” said Tim Turnham, executive director, Melanoma Research Foundation.

“Today’s expanded approvals continue to bring new treatment options to patients, and demonstrate the ongoing impact of immuno-oncology research.”


  1. Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) regimen receives expanded FDA approval in unresectable or metastatic melanoma across BRAF status [news release]. Princeton, NJ: Bristol-Myers Squibb; January 23, 2016. Accessed January 25, 2016.