The treatment of BPDCN by ELZONRIS in Manarini has been approved by the European Commission

Italian pharmaceutical and diagnostic private company Menarini Group announced today that the European Commission (EC) has granted ELZONRIS (tagraxofusp) a first-line drug for single-drug treatment of adult maternal plasma cell-like degenerative cell tumors (BPDCN). BPDCN is an invasive malignant blood disease with poor prognosis. The European Commission's decision follows positive comments from the European Medicines Agency (EMA) Human Medicines Commission (CHMP) in November 2020. In addition, the results of the largest prospective clinical trial conducted in BPDCN patients who have been treated in the first or past have provided the basis for the approval decision.ELZONRIS has been recognized as an orphan drug in Europe and is now the first approved BPDCN patient treatment drug in Europe and the first CD123 targeted drug approved in Europe to address this unsealed and significant medical need.“ For BPDCN patients in Europe, this is the first time they have the potential to benefit from this treatment for this malignant tumor," said Elcin Barker Ergun, CEO of Menarini Group. In keeping with our commitment to providing new and effective drugs to people affected by serious illnesses, we are working to make ELZONRIS available in the European market in the shortest possible time. ELZONRISis a CD123-targeted treatment approved by the FDA and sold in the United States by Stemline Therapeutics, now a member of the Manarini Group, starting in 2019.ELZONRIS ® approved by the U.S. Food and Drug Administration (FDA) in 2018 and is currently available for treatment in adult and pediatric BPDCN patients 2 years of age or older. (U.S. News Agency)