On November 2, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that the European Medicines Agency (EMA) has granted Orphan Drug designation to SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, NOV 2, 2015, View Source [SID:1234507876]). Recently, SL-401 received Orphan Drug designation from the EMA for acute myeloid leukemia (AML), and from the U.S. Food and Drug Administration (FDA) for the treatment of AML and BPDCN. Schedule your 30 min Free 1stOncology Demo! SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of BPDCN, AML, and other hematologic cancers. Stemline is evaluating SL-401 in multiple clinical programs, including an ongoing pivotal trial in BPDCN as well as trials in additional hematological cancers.
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Ivan Bergstein, M.D., Stemline’s CEO, commented, "We are pleased with the EMA’s decision to grant Orphan Drug designation to SL-401 for BPDCN, an aggressive and deadly disease with few effective treatment options." Dr. Bergstein continued, "SL-401 now has Orphan Drug status in the U.S. and Europe for both AML and BPDCN, which underscores the unmet medical need in these disorders, and provides us with options for potential accelerated clinical development."
About Orphan Drug Designation
Orphan Drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.