Yervoy ipilimumab regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending Yervoy ipilimumab from Bristol-Myers Squibb as first-line treatment of advanced malignant melanoma only in the context of research as part of a clinical study. The committee said there were no trials that directly compared 3 mg/kg Yervoy - the licensed dose - as monotherapy with the comparators, dacarbazine or vemurafenib, for the indication. NICE noted BMS had submitted data from the Phase III CA184-024 trial of 10 mg/kg ipilimumab plus dacarbazine, but the agency said there was "no robust evidence to support the view" that the 2 doses are clinically equivalent. Howeve r, NICE said BMS is conducting a Phase III trial to compare the 2 doses. The trial is slated to complete in 2016. Comments on the guidance are due March 18, with a second appraisal committee meeting scheduled for March 25. ...