Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that it met with the U.S. Food and Drug Administration's (the "FDA") Division of Oncology Drug Products (the "DODP"). The meeting provided a pathway for re-submitting CTI's New Drug Application (the "NDA") for pixantrone for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") including the potential for accelerated approval based on the PIX301 study results. This meeting follows CTI's receipt of the FDA's Office of New Drugs' (the "OND") response to CTI's appeal as announced on May 3, 2011, which allows CTI the opportunity to resubmit the NDA. On appeal, the FDA recommended the Company conduct an additional review of radiographs utilizing a new independent panel of radiologists to confirm the response and progression events noted in the pixantrone NDA. The DODP meeting also focused on the documents CTI proposed to provide regarding the circumstances of stopping the enrollment of the clinical trial prior to achieving the original planned patient accrual and the make-up of the new radiology expert panel. CTI also plans to address items noted in the FDA's Complete Response Letter. The DODP confirmed that the NDA would be reviewed within six months from the resubmission of the NDA. CTI anticipates filing the additional information later this year, and could obtain FDA approval in the first half of 2012.
"We are pleased to have the opportunity to meet with the review team from the DODP and to get their feedback on what will be required for a resubmission of our pixantrone NDA. We now have a pathway to move forward with resubmitting the NDA for potential accelerated approval of pixantrone in patients with multiple relapsed or refractory aggressive NHL, which is a stage of this disease for which there are no approved agents," stated Jack W. Singer, M.D., Chief Medical Officer of CTI. "We are excited to have been given this rare second opportunity for review of the NDA and we have made this resubmission our top priority."
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