Cell Therapeutics, Inc.
FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
Published in FDA Law Weekly, September 24th, 2009
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced 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),...
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Source: FDA Law Weekly (2009-09-24)
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