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news.Cell Therapeutics (CTI) has submitted an extended pediatric investigation plan (PIP) to the European Medicines Agency (EMEA), for advancing its regulatory process for submission of marketing authorisation application (MAA) for Pixantrone in the EU.
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Pixantrone is used for the treatment of relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).
CTI is expected to file the MAA later this year. The pediatric program is expected to study Pixantrone in pediatric patients aged 6 months to 18 years for comparing the safety and effectiveness of Pixantrone and doxorubicin in pediatric lymphoid cancers.
Following the discussions with CTI about the preclinical and clinical Pixantrone data, including PIX301, EMEA Pediatric Committee (PDCO) has recommended the extension of PPI because of Pixantrone’s clinical benefit to children in reducing long-term cardiotoxicity associated with current curative therapies. CTI submitted the original PIP in September 2009.
Jack Singer, chief medical officer of CTI, said: “Our discussions with the pediatric experts on the PDCO indicated that they agree with our belief that the need for a less toxic, more effective anthracycline-like agent is significant, not only in lymphoma, but in other tumors.
“We were pleased to accommodate their suggestions and have adjusted the PIP accordingly. Filing the updated PIP puts us one step closer to completing the MAA submission process.”