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

Menarini Group, a private italian pharmaceutical and diagnostics company, announced today that the European Commission (EC) has granted ELZONRIS (tagraxofusp) a first-drug treatment for adult maternal plasma cell-like degenerative tumors (BPDCN).
BPDCN is an invasive malignant blood disease with poor prognosis.
decision by the European Commission, the European Medicines Agency (EMA) Human Medicines Commission (CHMP) issued positive comments in November 2020.
, 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 unsolved 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.
our commitment to providing new and effective drugs to people affected by serious illness, we are working to make ELZONRIS available for sale in Europe in the shortest possible time.
"ELZONRIS is a CD123-targeted treatment approved by the FDA and sold in the United States by Stem Therapeuticlines(now a member of the Manarini Group) from 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.