Cell Therapeutics' Pixuvri cleared in EU for NHL

14 May 2012

US biotech firm Cell Therapeutics (Nasdaq and MTA: CTIC) last week received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). Pixuvri is the first approved treatment in the European Union in this patient setting.

The approval comes after a positive opinion from the European Medicines Agency’s advisory body (The Pharma Letter February 20). Clearance of the drug in the USA has been delayed since Cell Thera withdrew its New Drug Application with the Food and Drug Administration due to needed additional time to prepare for the review of the Pixuvri application earlier this year (TPL January 30).

Company plans to start own marketing of Pixuvri in second half of this year

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