EMA grants accelerated assessment for Elzonris to treat blastic plasmacytoid dendritic cell neoplasm.-Stemline Therapeutics

Stemline Therapeutics, Inc. , a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, announced 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).

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 FDA, with a target action date of 21 February, 2019, under the Prescription Drug User Fee Act (PDUFA).

Comment:Blastic plasmacytoid dendritic cell neoplasm (BPDCN) previously known as natural killer (NK) cell leukemia/lymphoma, is categorized by the World Health Organization (4th edition, 2008) under acute myeloid leukemia (AML). Most often, BPDCN presents with features of both lymphoma and leukemia. There are little data about BPDCN and there is no established treatment. The average age at diagnosis is 60 to 70 years. There are more men than women who are diagnosed with BPDCN.Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is very often misdiagnosed and under-reported.