FDA Postpones Pixantrone Review Due to Severe Weather Conditions Print E-mail
By M.E.Garza   
Tuesday, 09 February 2010 03:49
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration (the "FDA") informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.

This meeting is an open public forum for the presentation and discussion of safety and efficacy information contained in the pixantrone NDA for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).

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According to its usual practice the FDA has posted on its website briefing documents for the ODAC meeting that will be held to discuss the pixantrone NDA. The briefing information can be accessed on the FDA website.

"We are pleased with the time that the FDA has invested in connection with its review of our application for pixantrone.  We believe that many of the key issues they identified are addressed in our own briefing material which is now publically available as well," said James A. Bianco, M.D., CEO of Cell Therapeutics. "We are disappointed that the meeting was not able to take place as originally scheduled but understand that the severe weather conditions made travel safety an issue. We look forward to the ODAC meeting where our lymphoma expert physicians will discuss the clinical benefits of pixantrone with the advisory panel."

Shares of Cell Therapeutics Inc. plummeted Monday after the Food and Drug Administration raised serious questions about the safety and effectiveness of the biotech drugmaker's experimental cancer treatment.




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