CMP-positive opion for ELZONRIS (tagraxofusp) for the treatment of elastic plasmacytoid dendritic cell neoplasm (BPDCN), – Tech

– CHMP recommends approving ELZONRIS for first line treatment of adult patients with BPDCN

– When approved by the European Commission, ELZONRIS will be the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, Europe

Florence, Italy, November 13, 2020 / PRNewswire / – The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, today announced that the European Medicines Agency (EMA) Committee for Human Use of Medicinal Products (EMA) ELZONRIS (tagraxofusp) blast plasmacytoid dendritic cell Treatment of first-line adult patients with neoplasm (BPDCN) has disappointing results with an aggressive hematologic pathology. Positive opinion from CHMP was based on the largest prospective clinical trial conducted in patients with treatment-naïve or pre-treated DPDN.

The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU). If approved, ELZONRIS will be the first and only treatment for BPDCN, and to meet this high unmet medical need, CD123-targeted therapy is available prior to the EU.

“Today’s CHMP-positive opinion is an important milestone for European patients suffering from BPDCN, and demonstrates our strong commitment to improving the lives of those affected by difficult-to-treat cancer”, Commented Alkin Barker IrgunCEO of Menarini Group “BPDCN is a rare and aggressive disease that does not currently have EU approved therapeutic options. For this reason, we are particularly thrilled to be one step closer to making ELZONRIS available to BPDCN patients. “

ELZONRIS is a targeted therapy directed at CD123, first commercially launched United States Stemline Therapeutics, now part of the Menarini Group. Under the terms of the acquisition, Stemline shareholders received a non-traditional Contingent Price Right (CVR), to which each holder was entitled $ 1.00 Per share in cash upon completion of the first sale of ELZONRIS in any EU5 country after European Commission approval.

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


ELZONRIS® (tagraxofusp), a targeted therapy directed at CD123, is approved by the US Food and Drug Administration (FDA) and is commercially available in the US for the treatment of adult and pediatric patients with BPDCN at the age of two years or older. For complete information in the US, see www.ELZONRIS.com.

ELZONRIS is also being evaluated in additional clinical trials in other CD123 + indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others planned, Including a CD123 + all-commerce trial.


BPDCN, formerly staining NK-cell lymphoma, is an aggressive hematologic malignancy, often with dermal manifestations with historically poor results. BPDCN typically presents in the bone marrow and / or skin and may also include lymph nodes and viscera. The BPDCN cell of origin is a plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The Tech Health Organization (WHO) called the disease “BPDCN” in 2008; Previous names included blastic NK cell lymphoma and agranular CD4 + / CD56 + hematodermic neoplasm. For more information, please visit the BPDCN Disease Awareness website www.bpdcninfo.com.

About CD123

CD123 is a cell surface target, expressed on a wide range of mastications, including the blastocyst plasmacytoid dendritic cell neoplasm (BPDCN), some myeloproliferative neoplasms (MPNs), including chronic anelomonocytic leukemia (CMML) and myelofibrosis (MF). ), Include acute myeloidal leukemia. Potentially enriched in some AML subsets), myeloidoplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL) and some non-Hodgkin’s lymphoma (NHL). In addition, CD123 + cells have been detected in the tumor microenvironment of many solid tumors, as well as in some autoimmune disorders including dermal lupus and scleroderma.

About the Menarini Group

The Menarini Group is a major international pharmaceutical company in 140 countries, with a direct presence in over 70 countries. Its global platform extends across Europe, America, Central america, Africa, To Middle East And Asia Pacific, And generates $ 4.2 billion In annual sales. Menarini is committed to oncology, already a commercial product in the US and several new investigational drugs in development for the treatment of various types of tumors. For over 130 years, Menarini has also been investing in the development, production, and distribution of pharmaceuticals to serve patients and physicians around the world, with a full portfolio of products covering many therapeutic areas.

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