SEATTLE & MILAN--(BUSINESS WIRE)--
CellTherapeutics today 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.
As a condition of approval, CTI has agreed to have available the PIX306
clinical trial results by June 2015.