On November 20, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, reported that the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming centralized Marketing Authorization Application (MAA), which Stemline expects to complete in the first quarter of 2019, for ELZONRIS (tagraxofusp; SL-401) in blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, NOV 20, 2018, View Source [SID1234532630]).
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Under European Union legislation, a medicinal product of major public health interest may be reviewed under an accelerated assessment procedure. Accelerated assessment can significantly reduce the timeframe for the EMA Committee for Medicinal Products for Human Use (CHMP) to review an MAA.
In the U.S., ELZONRIS was granted breakthrough therapy designation for the treatment of patients with BPDCN. The Biologics License Application (BLA) for ELZONRIS in BPDCN has received Priority Review status from the U.S. Food and Drug Administration (FDA), with a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).
Ivan Bergstein, M.D., Stemline’s CEO, commented, "The granting of accelerated assessment to the ELZONRIS planned MAA underscores the robust clinical data, clear unmet medical need, and the heightened awareness of BPDCN worldwide. We look forward to working closely with the EMA to ensure that this important new treatment reaches patients in the European Union as quickly as possible. In the U.S., we are continuing our interactions with the FDA, and our commercial team is poised to rapidly execute a U.S. launch following possible approval of ELZONRIS for BPDCN."