Biopharmaceutical company Cell Therapeutics Inc (CTIC) Tuesday announced that the US Food and Drug Administration's Division of Oncology Products has notified to the company that its October 2011 resubmitted New Drug Application is considered a complete, Class 2 response to the FDA's April 2010 complete response letter.
The company further noted that the FDA has set a Prescription Drug User Fee Act, or PDUFA, goal date of April 24, 2012 for a decision on the new drug application, or NDA.
The NDA seeks accelerated approval of pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.
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