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.