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ODAC to review pixantrone

January 4, 2012 2:16 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on Feb. 9 to discuss a resubmitted NDA from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy. The PDUFA date is April 24. The biotech is seeking accelerated approval based on the Phase III PIX301 trial, in which pixantrone met the primary endpoint of a higher complete response rate than standard chemotherapy. ...