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news.Cell Therapeutics (CTI) has received approval from the European Medicines Agency (EMA) for its Pixuvri (pixantrone dimaleate) pediatric investigation plan (PIP) for the treatment of lymphoid malignancies and solid tumors in children between the ages of six months and 18 years.
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Pixantrone is a new aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents.
Previously, the Pediatric Committee (the PDCO) of the EMA adopted an opinion agreeing to the PIP and a deferral of the initiation of the clinical studies until after the drug receives EMA approval.
CTI has submitted a marketing authorisation application (MAA) for Pixuvri approval in Europe as monotherapy for the treatment of adult patients with multiply relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).
CTI expects that the EMA will make a determination regarding the acceptance of the Pixuvri MAA submission for review this month.