Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that, following discussions with the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), the CHMP may issue an opinion on CTI's Marketing Authorization Application ("MAA") for Pixuvri in mid-February. In the interim, CTI will continue to work with the CHMP on the Summary of Product Characteristics and other labeling items for Pixuvri. CTI is seeking an authorization to market Pixuvri in the E.U. for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin's B cell lymphomas ("NHL"). If approved by the EMA, Pixuvri would address an unmet medical need, as there are no approved therapies for these patients.
In the U.S., the Food and Drug Administration ("FDA") has set a Prescription Drug User Fee Act ("PDUFA") goal date of April 24, 2012 for a decision on the New Drug Application for Pixuvri in the same indication.
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