Menarini Receives European Commission Approval of ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

- ELZONRIS is the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, in Europe

- Approval is based on the results of the largest prospective clinical trial ever conducted in patients with treatment-naïve or previously-treated BPDCN

FLORENCE, Italy, Jan. 21, 2021 /PRNewswire/ -- 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.

"For the first time, patients living with BPDCN in Europe will have the possibility to benefit from a treatment tailored against this aggressive malignancy," commented Elcin Barker Ergun, CEO of the Menarini Group. "The approval of ELZONRIS can enable a significant change in the therapeutic approach for BPDCN, since it provides clinicians with a targeted therapy to help patients suffering from this terrible disease. We are working to make ELZONRIS available in Europe in the shortest time possible, as part of our commitment to deliver innovative and effective medicines for people affected by serious health conditions".

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.

About ELZONRIS in the European Union

ELZONRIS (tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.