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Stemline - Model ELZONRIS - Novel Targeted Therapy
ELZONRISTM (tagraxofusp, SL-401) — ELZONRIS is a novel targeted therapy directed to the interleukin-3 (IL-3) receptor-α (CD123), a target present on a wide range of malignancies. ELZONRIS was approved by the US Food and Drug Administration (FDA) on December 21, 2018, for the treatment of adult and pediatric patients, 2 years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In January 2019, a marketing authorization application (MAA) for ELZONRIS for the treatment of patients with BPDCN was submitted to the EMA. Previously, the EMA granted the MAA accelerated assessment status. In parallel, Stemline is evaluating ELZONRIS in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and others.