On April 25, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the pivotal trial results of ELZONRIS (tagraxofusp), a targeted therapy directed to CD123, in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) have been published in the April 25 issue of theNew England Journal of Medicine (Press release, Stemline Therapeutics, APR 25, 2019, View Source [SID1234535620]).
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ELZONRIS (tagraxofusp-erzs) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of BPDCN in adults and pediatric patients two years and older, and is commercially available in the U.S.
Andrew Lane, M.D., Ph.D., Assistant Professor at Harvard Medical School and Dana-Farber Cancer Institute and a co-lead author of the manuscript, offered: "This publication by the New England Journal of Medicine highlights the increasing recognition of BPDCN in the medical community. As this landmark paper lays out, treatment with tagraxofusp resulted in a high remission rate while maintaining a predictable and a manageable safety profile, providing data supporting the first-ever approved agent for treatment of this aggressive malignancy. We thank our patients and collaborators for the years of research that have led to a new era in the therapy of BPDCN."
Ivan Bergstein, M.D., Chief Executive Officer of Stemline, commented "The publication of these pivotal data in the New England Journal of Medicine underscores both the clinical benefit of ELZONRIS for patients with BPDCN as well as the growing worldwide awareness of this serious hematologic malignancy. We are very thankful to the patients, their families, and the investigators who helped make this breakthrough product a reality."
About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MMA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia (AML).
About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. 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 (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.
About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.