Pomalidomide regulatory update

FDA cancelled a Nov. 8 meeting of the Oncologic Drugs Advisory Committee (ODAC) that was scheduled to discuss an NDA from Celgene for pomalidomide and an sNDA from Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) for Exjade deferasirox. Celgene is seeking approval for pomalidomide in combination with dexamethasone to treat patients with relapsed and refractory multiple myeloma (MM) who have received >=2 prior therapies. Celgene said in a statement that the PDUFA date for the thalidomide analog remains Feb. 10, 2013. Celgene could not be reached for comment, while FDA declined to disclose details. ...