Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the Pediatric Committee (the "PDCO") of the European Medicines Agency ("EMA") has adopted an opinion agreeing to CTI's Pixuvri® (pixantrone dimaleate) Pediatric Investigation Plan ("PIP") for the treatment of lymphoid malignancies and solid tumors in children between ages of 6 months and 18 years. This positive opinion clears the way for CTI to submit its Marketing Authorization Application ("MAA") in the E.U. later this quarter for pixantrone for the treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").
CTI submitted the updated PIP to the PDCO in July 2010 after the PDCO recommended CTI expand the original PIP to include pixantrone's potential clinical benefit of reducing long-term cardiotoxicity associated with current curative therapies in children. The expanded PIP was accepted for review by the PDCO in August 2010. The recommendation from the PDCO came following discussions with CTI about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancers and solid tumors. The PDCO also recommended deferral of the initiation of the clinical studies until after the drug receives EMA approval. The Company expects the EMA's decision on adoption of the PDCO's recommendations later this quarter.
Pixantrone was granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL).
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