CTI Submits Pediatric Investigation Plan To EMEA For Approval Of Pixantrone

Cell Therapeutics (CTI) has submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA) as part of the required filing process for approval of pixantrone for treating relapsed or refractory, aggressive non-Hodgkin’s Lymphoma (NHL) in Europe.

Reportedly, the PIP outlines how the company proposes to study the drug in children in order to benefit child health.

Pixantrone (BBR 2778) is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents

The company said that it has recently received a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010, in the US regarding CTI’s New Drug Application (NDA) for pixantrone as potential treatment for relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).

Jack Singer, CMO at CTI, said: “PIPs were introduced by the European Commission to help ensure that medicines that may have benefit in pediatric indications are evaluated in children. Anthracyclines are a mainstay in the treatment of childhood leukemias, lymphomas and solid tumors but long-term cardiotoxicity represents a significant issue. We are planning to evaluate safety and efficacy of pixantrone in pediatric cancer patients.”