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FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
Press Release
Source: Cell Therapeutics, Inc.
On Saturday September 5, 2009, 1:30 am EDT
Buzz up! 0 Print.Companies:Cell Therapeutics, Inc.
SEATTLE, Sept. 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding CTI's NDA for pixantrone as potential treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). Pixantrone has fast track designation for the relapsed / refractory aggressive NHL application.
"The 18 month follow up PIX 301 pivotal trial data continues to demonstrate further improvement in primary and secondary endpoints including Complete Remission / Complete Remission unconfirmed(CR/CRu), Progression Free Survival (PFS) and Overall Survival over standard chemotherapy. We look forward to providing the four month safety and efficacy update to the FDA and working 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 estimates that pixantrone could be available to patients in the U.S. early in the second quarter of 2010.