Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
- Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval1
- Demonstrated significantly superior progression-free survival vs. Yervoy alone in CheckMate -067 with the first and only FDA-approved combination of immune checkpoint inhibitors1,2
- FDA also expands use of Opdivo as single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients, based on accelerated approval1
- With this seventh approval for Opdivo in just over a year, and the fourth for late-stage melanoma, more patients fighting cancer now have access to Immuno-Oncology treatment options1
(PRINCETON, NJ, January 23, 2016) – Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.1 This indication is approved under accelerated approval based on progression-free survival (PFS).1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which PFS and overall survival (OS) were co-primary endpoints.1,2
Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; and embryofetal toxicity.1 Please see the Important Safety Information section below, including Boxed WARNING for Yervoy regarding immune-mediated adverse reactions.
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