Therapy Areas: Oncology
Menarini Receives European Commission Approval of Elzonris for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
22 January 2021 - - The European Commission 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, Italian pharmaceutical and diagnostics company The Menarini Group said.

The EC 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 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 US Food and Drug Administration in 2018, where it is currently available for the treatment of BPDCN in adult and pediatric patients, two years or older.

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.

Elzonris (tagraxofusp), a targeted therapy directed to CD123, is approved by the US Food and Drug Administration and commercially available in the US for the treatment of adult and pediatric patients, two years or older, with BPDCN.

Elzonris is also being evaluated in additional clinical trials in other indications, including chronic myelomonocytic leukemia, myelofibrosis, acute myeloid leukemia, and others are planned.

BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes.

BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera.

The BPDCN cell of origin is the plasmacytoid dendritic cell precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers.

The World Health Organization termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm.

CD123 is a cell surface target expressed on a wide range of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms including chronic myelomonocytic leukemia and myelofibrosis, acute myeloid leukemia (and potentially enriched in certain AML subsets), myelodysplastic syndrome, and chronic myeloid leukemia.

CD123 has also been reported on multiple myeloma, acute lymphoid leukemia, hairy cell leukemia, Hodgkin's lymphoma, and certain Non-Hodgkin's lymphomas.

In addition, CD123+ cells have been detected in the tumor microenvironment of several solid tumors as well as in certain autoimmune disorders including cutaneous lupus and scleroderma.
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