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FDA cancels pomalidomide, Exjade meeting

October 4, 2012 12:59 AM UTC

FDA cancelled a Nov. 8 meeting of the Oncologic Drugs Advisory Committee (ODAC) that was scheduled to discuss an NDA from Celgene Corp. (NASDAQ:CELG) for pomalidomide and an sNDA from Novartis AG (NYSE:NVS; SIX:NOVN) for Exjade deferasirox. Celgene is seeking approval for pomalidomide in combination with dexamethasone to treat patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. Celgene said in a statement that the PDUFA date for the thalidomide analog remains Feb. 10, 2013. Celgene was up $0.57 to $78.99 on Wednesday. Celgene and FDA could not be reached for comment. ...