Ipilimumab has received FDA priority review status, according to Bristol-Myers Squibb. The review will focus on use of the drug in adult patients with previously treated advanced melanoma.
The filing was based on a preliminary analysis of data from the MDX010-020 trial (American Society of Clinical Oncology [ASCO] abstract 4).
In the phase III, double-blind, multicenter trial (125 centers in 13 countries), 676 patients (mean age, 66) with unresectable stage III/IV melanoma were randomized 3:1:1 to three treatment arms: ipilimumab plus gp100 vaccine peptides 209-217; ipilimumab plus placebo; and gp100 vaccine plus placebo. Ipilimumab improved overall survival, although combining the drug with the gp100 vaccine did not provide an additional survival benefit.
The FDA is expected to deliver a decision by December 25, 2010, according to the company.