Published on May 11, 2012 at 4:25 AM
Cell Therapeutics, Inc.("CTI") (Nasdaq and MTA: CTIC) today announced that it has received conditional marketing authorization from the European Commission ("EC") 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 ("EU") in this patient setting.
The decision allows CTI to market Pixuvri in the 27 Member States of the EU as well as in Iceland, Liechtenstein and Norway. CTI expects to make Pixuvri immediately available in the EU, initially through a named patient program. CTI plans to market and commercialize Pixuvri with its own sales force in the EU starting in the 2nd half of 2012.
"Pixuvri is a welcome addition in our efforts to control disease progression in these late-stage aggressive NHL patients as it has demonstrated a significant benefit compared to standard treatments used at this stage of disease. By addressing this unmet need, Pixuvri adds an important treatment option for patients," said Norbert Schmitz, M.D., Ph.D., Head of the Department of Hematology, Askelepios Klinik St. Georg in Hamburg, Germany.
"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," said James A. Bianco, M.D., CEO of CTI.
SOURCE Cell Therapeutics, Inc.