EMA approves CTI's Pixuvri Pediatric Investigation Plan for lymphoid malignancies and solid tumors

Nov 17 2010

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the European Medicines Agency ("EMA") approved CTI's Pixuvri (pixantrone dimaleate) Pediatric Investigation Plan ("PIP") for the treatment of lymphoid malignancies and solid tumors in children between the ages of six months and 18 years. Previously, the Pediatric Committee (the "PDCO") of the EMA adopted an opinion agreeing to the PIP and a deferral of the initiation of the clinical studies until after the drug receives EMA approval.  CTI has submitted a Marketing Authorization Application ("MAA") for Pixuvri approval in Europe as monotherapy for the treatment of adult patients with multiply relapsed or refractory, aggressive non-Hodgkin's lymphoma ("NHL"). CTI expects that the EMA will make a determination regarding the acceptance of the Pixuvri MAA submission for review this month.

SOURCE Cell Therapeutics, Inc.