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news.The US Food and Drug Administration (FDA) has determined that additional time is required to complete the review of Bristol-Myers Squibb's (BMS) biologics license application (BLA) for Ipilimumab in pre-treated advanced melanoma, and has moved its decision date from 25 December 2010 to 26 March 2011.
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Ipilimumab is a human monoclonal antibody intended to be used as a drug to activate the immune system.
In response to the FDA’s decision, BMS has 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.
BMS said that it looks forward to continuing its close collaboration with the FDA on this application.