FDA Clears BMS Melanoma Treatment
The FDA has cleared Bristol-Myers Squibb’s new mixed-drug regimen for the treatment of advanced melanoma, in a first-ever approval of an immune-oncology combination.
The decision was based on a study showing Opdivo (nivolumab) plus Yervoy (ipilimumab) to be effective in reducing skin cancer tumors and risk of disease progression.
The FDA approved Opdivo for treatment of melanoma last December and Yervoy in March 2011.
Both drugs are PD-1 inhibitors, which work by identifying routes where melanoma cells can avoid detection and stimulating T-cells to attack them. The FDA approved the only other PD-1 inhibitor, Merck’s Keytruda (pembrolizumab), last week. — Victoria Pelham