CellTherapeutics (CTIC) Gets Conditional EC Marketing Authorization for Pixuvri
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CellTherapeutics (Nasdaq: CTIC) announced that it has 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. Pixuvri is the first approved treatment in the European Union in this patient setting.
The decision allows CTI to market Pixuvri in the 27 Member States of the EU. CTI expects to make Pixuvri immediately available in the EU, initially through a named patient program. CTI plans to market and commercialize Pixuvri in the EU in 2H2012.
A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
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The decision allows CTI to market Pixuvri in the 27 Member States of the EU. CTI expects to make Pixuvri immediately available in the EU, initially through a named patient program. CTI plans to market and commercialize Pixuvri in the EU in 2H2012.
A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
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