The European Commission (EC) has awarded a conditional marketing authorization approval for Cell Therapeutics' Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL).
As per the approval, Cell Therapeutics will be able to market Pixuvri in the 27 Member States of the European Union (EU) as well as in Iceland, Liechtenstein and Norway, with its own sales force starting in the second half of 2012.
CTI MD and CEO James Bianco said, "The EC's decision for Pixuvri is an important milestone for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas who currently have no approved option to treat their disease, and we are moving rapidly to make this product available for patients in the EU."
CTI forwarded the marketing authorization application based on the PIX 301 phase 3 clinical trial, which demonstrated that a greater proportion of patients achieved a complete response or unconfirmed complete response to Pixuvri than a comparator chemotherapy medicine.
According to trials, the most frequent side effect was suppression of the patient's bone marrow, resulting in low levels of white blood cells, platelets and red blood cells.
Pixuvri, a novel aza-anthracenedione, will be marketed in the EU as Pixuvri 29 mg powder for concentrate for solution for infusion.
The US is yet to approve marketing authorization for CTI's Pixuvri.
