Posted by Michael Wonder on 22 Jan 2021
Menarini receives European Commission approval of Elzonris (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm
21 January 2021 - Elzonris is the first approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the first approved CD123 targeted therapy, in Europe.
Menarini announced today that the European Commission has granted a marketing authorisation, for Elzonris (tagraxofusp) as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, a rare, aggressive haematologic malignancy with dismal outcomes.
The European Commission decision follows the positive opinion received from the Committee for Medicinal Products for Human Use of the European Medicines Agency 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 blastic plasmacytoid dendritic cell neoplasm.
