Boost for Bristol-Myers as US FDA approves Yervoy for metastatic melanoma

There was good news for US drug major Bristol-Myers Squibb (NYSE BMY) on Friday, as the Food and Drug Administration approved its potential blockbuster drug Yervoy (ipilimumab) for the treatment of patients with unresectable (inoperable) or metastatic melanoma, albeit with safety warnings.

The FDA decision was not a foregone conclusion because last November the agency called for more time to review the firm’s Biologival License Application, after B-MS submitted an additional analysis which the ageancy considered to be a major amendment to the drug’s BLA.

Yervoy is the first new treatment for melanoma in 13 years. “This is really the first time in the melanoma field that there is a drug that extended survival in a meaningful way,” said Gerald Linette, an assistant professor of medicine at Washington University in St Louis, who participated in a clinical trial of the drug.