Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has determined that additional time is required to complete the review of the biologics license application (BLA) for ipilimumab in pre-treated advanced melanoma, and has moved its decision date from December 25, 2010 to March 26, 2011.
In response to an FDA request, Bristol-Myers Squibb submitted further analysis of data pertaining to the current application for pre-treated advanced melanoma and the agency considers this to be a major amendment to the drug’s BLA.
Bristol-Myers Squibb continues to be very encouraged by its interactions with the FDA and remains confident in the overall development program for ipilimumab. The company looks forward to continuing its close collaboration with the FDA on this application and addressing an important unmet medical need for patients with advanced melanoma. Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities worldwide for pre-treated advanced melanoma.
Bristol-Myers Squibb Company