Posted from: Friday, October 30, 2015 - 12:19 PM - Present

Combination Immunotherapy Treatment for Melanoma Approved

October 1, 2015 – The U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) in combination with Yervoy (ipilimumab-BMS) for patients with unresectable or metastatic BRAF wild-type melanoma. Both Opdivo and Yervoy are immune checkpoint inhibitors that target separate checkpoint pathways (PD-1 and CTLA-4, respectively) to help the body’s own immune system attack cancer cells. Individually, both drugs been approved by the FDA as monotherapy for the treatment of advanced melanoma. Opdivo received additional approval for squamous NSCLC.

Combination approval is based on data from the CheckMate-069 Study, which showed an increased objective response rate for patients receiving the Opdivo + Yervoy combination versus Yervoy alone (60% vs 11%). Results from the study also showed an increase in median progression-free survival (8.9 months vs 4.7 months) and a 60% reduction in the risk or progression for the combination compared to Yervoy alone. Full FDA approval will be determined after ongoing clinical trials to verify study results.

It is estimated that 73,870 melanoma cases will be diagnosed in the U.S. in 2015 with approximately half of that number expected to be BRAF Wild-Type.

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Last Updated Thursday, March 23, 2017 - 08:53 AM.