EU approves Elzonris for blastic plasmacytoid dendritic cell neoplasm.- Menarini Group

The Menarini Group announced that the European Commission (EC) has granted a marketing authorization, for Elzonris (tagraxofusp) as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare, aggressive hematologic malignancy with dismal outcomes. The EC decision follows the positive opinion received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in November 2020, and is based on the results of the largest prospective clinical trial ever conducted in patients with treatment-naïve or previously-treated BPDCN. Elzonris has been granted orphan designation in Europe, and is now the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy in Europe to address this high unmet medical need.