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news.Cell Therapeutics (CTI) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Pixuvri (pixantrone dimaleate) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
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CTI said that the application submission follows a positive opinion from the EMA’s Pediatric Committee (the PDCO), where PDCO agreed to CTI’s Pediatric Investigation Plan (PIP) for Pixuvri.
CTI CEO James Bianco said that it was an important milestone for CTI, and underscores their commitment to making Pixantrone available to patients.
Principal investigator on the study Ruth Pettengell said that PIX301 was not only the first and only randomised trial in this patient population, it was also the largest study conducted for patients with multiply relapsed and refractory aggressive NHL.
Pixantrone was granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL).