FLORENCE, January 21, 2021 – The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today 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.
ELZONRIS is a targeted therapy directed to CD123, already approved by the FDA and marketed in the US since 2019 by Stemline Therapeutics, now part of the Menarini Group.
ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) in 2018, where it is currently available for the treatment of BPDCN in adult and pediatric patients, two years or older.
The clinical study that led to approval by the FDA was supported in part by The Leukemia & Lymphoma Society's Therapy Acceleration Program® (TAP). This was the third approval for a TAP supported project.