Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that CTI's Marketing Authorization Application ("MAA") seeking approval for Pixuvri™ (pixantrone dimaleate) for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") was validated and accepted for review by the European Medicines Agency ("EMA"). Validation indicates that the application is complete and that the EMA's review process has begun.
"We look forward to working with our rapporteurs and the EMA during their review process in an effort to bring pixantrone to patients for whom there are currently no available drugs in this setting," said James A. Bianco, M.D., CEO of CTI.
The EMA's review of the MAA will follow the centralized marketing authorization procedure and, if the MAA is approved, Pixuvri expects to receive marketing authorization in the E.U. member states.
The Company also plans, in 2011, to submit a marketing application in selected other countries beginning with Switzerland.
Pixantrone was initially granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL), but based on the expansion of the current MAA to the broader aggressive NHL population, CTI has agreed to withdraw the orphan designation from the E.U. register.
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