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FDA postpones ODAC session for ipilimumab

November 23, 2010 2:00 AM UTC

FDA's Oncologic Drugs Advisory Committee will no longer discuss a BLA from Bristol-Myers Squibb Co. (NYSE:BMY) for metastatic melanoma candidate ipilimumab at the committee's Dec. 2 meeting. FDA said it postponed that portion of the meeting to complete the review of additional data submitted by Bristol-Myers. This month, the agency extended the PDUFA date for human mAb against CTLA-4 receptor to March 26, 2011, from Dec. 25. Ipilimumab is under Priority Review for metastatic melanoma. FDA said a new date for ODAC to discuss the compound has not yet been scheduled. ...