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European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP)Tentatively Scheduled to Render an Opinion on PixuvriTM Marketing Authorization Application on January 19, 2012
Date:12/4/2011

SEATTLE, Dec. 5, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today an update on the status and progress of its European marketing authorization application ("MAA") for Pixuvri. CTI is seeking a license to market Pixuvri in the E.U. for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") who have failed two or more prior lines of therapy. CTI received the CHMP's day 180 list of outstanding issues, which unlike the day 120 letter, contained only one remaining major objection to CTI's MAA and items not deemed to be major issues. CTI plans on submitting its responses to the day 180 list of outstanding issues by December 19, 2011. If the responses satisfy the outstanding objection and the CHMP does not require an oral explanation a positive recommendation on the approval of Pixuvri could be made at the January 19th meeting of the CHMP.

"We believe we have made excellent progress working collegially with the E.U. rapporteurs on addressing items raised in the day 120 list of outstanding issues because we resolved all major objections other than the one major remaining objection in the day 180 letter," stated James A. Bianco,  M.D, CEO of CTI.

To address the remaining major objection, the CHMP required that CTI provide a literature review of mechanisms of rituximab resistance and analyses that demonstrate the efficacy of Pixuvri in patients with prior rituximab treatment, as well as information to address some additional questions that were not deemed to be major issues and could be addressed by additional analyses of currently available data.

On November 29th CTI met with the rapporteurs and team members from the EMA for a clarification meeting at which CTI and its clinical expert presented the results of its literature review, additional supportive analyses regarding the efficacy of pixantrone across response rates and progression free surviv
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SOURCE Cell Therapeutics, Inc.
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