The Menarini Group, an Italy-based pharmaceutical and diagnostics company, announced on Thursday that it has received marketing authorisation from the European Commission for ELZONRIS (tagraxofusp) as monotherapy intended for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

This approval follows the positive opinion received from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is based on the outcome of the clinical trial conducted in patients with treatment-naïve or previously-treated BPDCN.

The product has received 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.