Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.
Ipilimumab is Bristol-Myers Squibb’s second drug under priority review by the FDA this year. A priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on FDA’s six month goal for completing priority reviews, the projected FDA action date is December 25, 2010.
The filing is based on results from the primary analysis of the pivotal MDX010-020 trial, which were published online in the New England Journal of Medicine and presented during a plenary session at the 46th Annual Meeting of the American Society of Clinical Oncology in June 2010. The study compared the overall survival rate of patients who received ipilimumab plus the gp100 vaccine (3 mg/kg and 1mg/kg every three weeks for four doses; n=403), ipilimumab alone (3 mg/kg every three weeks for four doses; n=137) and the control therapy of gp100 alone (n=136).
Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities for the treatment of adult patients with previously treated advanced melanoma.
Date: August 18, 2010
Source: Bristol-Myers Squibb Company
Filed Under: Drug Discovery