Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it 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. The PIP outlines how the company proposes to study the drug in children in order to benefit child health.
"PIPs were introduced by the European Commission to help ensure that medicines that may have benefit in pediatric indications are evaluated in children," said Jack Singer, CTI's Chief Medical Officer. "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."
CTI recently received a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 in the U.S. regarding CTI's New Drug Application (NDA) for pixantrone as potential treatment for relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).