EU extends Melanoma indication of Yervoy (BMS)

The EU has approved an extended indication for Yervoy (ipilimumab), from BMS, for the first-line treatment of adult patients with advanced unresectable or Metastatic Melanoma (MM). As approved in 2011, Yervoy was indicated for the treatment of adult patients with previously-treated advanced MM.

The extension of the Marketing Authorisation was supported by data derived from phase 2 and 3 studies conducted in advanced melanoma patients, as well as from two retrospective observational studies in first-line advanced melanoma patients who were treated with ipilimumab 3mg/kg monotherapy. The estimated 1 year survival rates were 59.5% and 49.3% in the two retrospective observational studies. The estimated 1-year and 2-year survival rates for chemotherapy-naive patients pooled across Phase II and III clinical trials were 54.1% and 32% respectively. This extension of the indication for ipilimumab is applicable to all 28 European Union member states as well as Iceland and Norway.