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news.Cell Therapeutics' (CTI) marketing authorisation 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).
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Reportedly, the EMA’s review of the MAA will follow the centralised marketing authorisation procedure and, if the MAA is approved, Pixuvri expects to receive marketing authorisation in the EU member states.
CTI CEO James Bianco said that they look forward to working with their 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.
CTI 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 EU register.