Cell Therapeutics, Inc. or CTI (CTIC) Thursday said that CTI's Marketing Authorization Application or MAA seeking approval for Pixuvri (pixantrone dimaleate) for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma was validated and accepted for review by the European Medicines Agency or EMA. The validation indicates that the application is complete and that the EMA's review process has started.
The biopharmaceutical company stated that 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.
Pixantrone was initially granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma or 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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