Stemline Therapeutics Announces Submission of European Marketing Authorization Application (MAA) for ELZONRIS

NEW YORK, NY, USA I January 07, 2019 I Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that it has submitted the marketing authorization application (MAA) for ELZONRIS (tagraxofusp) to the European Medicines Agency (EMA). The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the EMA granted the ELZONRIS MAA accelerated assessment.

On December 21, 2018, ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) for the treatment of BPDCN in adult and pediatric patients, two years and older, in both treatment-naïve and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.

“The submission of the ELZONRIS MAA is another major step forward for providing this important targeted treatment to patients, globally,” said Ivan Bergstein, M.D., CEO of Stemline Therapeutics. “We look forward to working closely with the EMA to ensure this treatment is available to patients as quickly as possible. In parallel, our commercial team is continuing its ongoing effort to raise awareness of both CD123 testing and BPDCN worldwide. Potential European approval offers us an opportunity to significantly increase the number of patients who may benefit from ELZONRIS.”

About ELZONRIS™
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other CD123 positive diseases.

About BPDCN
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About Stemline Therapeutics
Stemline Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. In December 2018, the FDA approved ELZONRIS, a targeted therapy directed to CD123, for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted accelerated assessment to the marketing authorization application (MAA) of ELZONRIS in patients with BPDCN, which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and others. Other Stemline clinical candidates include SL-801, a novel oral small molecule reversible inhibitor of XPO1, which is currently in a Phase 1 trial of patients with advanced solid tumors and recent data was presented at the European Society of Medical Oncology (ESMO) annual conference; and SL-701, an immunotherapeutic which has completed a Phase 2 trial in patients with second-line glioblastoma and recent data were presented at the Society for Neuro-Oncology (SNO) annual conference.

SOURCE: Stemline Therapeutics

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