Cell Therapeutics updates on Pixuvri

Seattle, USA-based Cell Therapeutics (Nasdaq and MTA: CTIC) says that it has voluntarily withdrawn its New Drug Application for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy. Shares of Cell Therapeutics fell 17% to $1.10 in pre-market trading on Monday.

The NDA was withdrawn because, after communications with the US Food and Drug Administration, Cell Thera needed additional time to prepare for the review of the Pixuvri NDA by the FDA's Oncologic Drugs Advisory Committee (ODAC) at its February 9, 2012 meeting. Prior to withdrawing the NDA, the company requested that the FDA consider rescheduling the review of the Pixuvri NDA to the ODAC meeting to be held in late March.

The agency was unable to accommodate Cell Thera's request to reschedule, and given the April 24, 2012 Prescription Drug User Fee Act (PDUFA) date, the only way to have Pixuvri possibly considered at a later ODAC meeting was to withdraw and later resubmit the NDA, which the company plans to do in 2012.