Bristol-Myers Squibb announced Thursday that European regulators approved Yervoy (ipilimumab) for the treatment of adults with previously-treated advanced melanoma. The drugmaker noted that the immunotherapy, which was cleared in the US earlier in the year, is the “first and only approved therapy for pre-treated unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival,” and the first new treatment for the disease in more than 20 years.
The decision by the European Commission, which followed a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in May, was based on results of a late-stage trial released last year. Data showed that the one- and two-year estimated survival rates for patients who received Yervoy were 46 percent and 24 percent, respectively, compared with 25 percent and 14 percent in the comparator arm, the company noted.
“With an average survival time on diagnosis of six to nine months, patients with advanced melanoma have had little hope,” remarked Ron Cooper, Bristol-Myers Squibb’s European president. The European approval “is a milestone for patients with advanced disease and is the first outcome of Bristol-Myers Squibb’s commitment to immuno-oncology,” Cooper added.
The drugmaker indicated that it will work with health authorities in European countries to expedite the availability of the drug. According to analysts, sales of Yervoy may reach more than $1 billion.