WASHINGTON (dpa-AFX) - Cell Therapeutics, Inc.(CTIC) said Thursday that it has received conditional marketing authorization from the European Commission for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas.
Pixuvri is the first approved treatment in the European Union in this patient setting.
The PIX 301 phase 3 clinical trial, which formed the basis for the marketing authorization application, showed that a greater proportion of patients achieved a complete response or unconfirmed complete response to Pixuvri than a comparator chemotherapy medicine, and patients receiving Pixuvri survived for longer without their disease progressing.
The decision allows Cell Therapeutics to market Pixuvri in the 27 Member States of the EU as well as in Iceland, Liechtenstein and Norway.
The company said it expects to make Pixuvri immediately available in the EU, initially through a named patient program.
The company plans to market and commercialize Pixuvri with its own sales force in the EU starting in the 2nd half of 2012.
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