EMEA validates Cell Therapeutics' expanded pixantrone PIP

Seattle, USA-based Cell Therapeutics (CTI) says it has received notice that the European Medicines Agency (EMEA) has validated the expanded Pediatric Investigation Plan (PIP) that the company filed in last month for pixantrone for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL; The Pharma Letter July 6).

Following the validation, the EMEA Pediatric Committee (PDCO) will review and comment or approve the content of pediatric plan. Once the PIP is approved, CTI will submit the Marketing Authorization Application for pixantrone in the European Union later this year. The pediatric program will study pixantrone in pediatric patients aged six months to 18 years with the goal of determining the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers.

"We are very pleased that the EMEA has validated the expanded PIP for pixantrone, as there is a real need for a less toxic, more effective anthracycline-like treatment option not only in lymphoma, but also possibly in other tumors," said Jack Singer, chief medical officer of CTI.