Cell Therapeutics, Inc. (CTI) announced that the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone. CTI is in the process of preparing a Marketing Authorization Application (MAA) in the European Union for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
"We are pleased that the AIFA has approved the NerPharMa facility to manufacture pixantrone as we continue to receive positive feedback on the clinical trial results from leading clinicians in Europe and make progress in the submission of the MAA in Europe," said Craig W. Philips, president of CTI.
Nerviano Medical Sciences is the largest pharmaceutical research and development facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.