FDA Sets Action Date for Review of CTI's Pixantrone NDA
Tue, 09/08/2009 - 5:06am
Cell Therapeutics, Inc. has announced that the FDA has notified CTI that a Prescription Drug User Fee Act(PDUFA) action date of April 23, 2010 under standard review has beenestablished regarding CTI's NDA for pixantrone as potential treatment forrelapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). Pixantrone hasfast track designation for the relapsed / refractory aggressive NHLapplication. "The 18 month follow up PIX 301 pivotal trial data continues todemonstrate further improvement in primary and secondary endpoints includingComplete Remission / Complete Remission unconfirmed(CR/CRu), Progression FreeSurvival (PFS) and Overall Survival over standard chemotherapy. We lookforward to providing the four month safety and efficacy update to the FDA andworking with them toward potential approval," said James A. Bianco, M.D.,Chief Executive Officer of CTI. Based on the user fee goal date, if pixantrone is approved, CTI estimatesthat pixantrone could be available to patients in the U.S. early in the secondquarter of 2010.