On January 30, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the European Medicines Agency (EMA) has completed its validation of the Marketing Authorization Application (MAA) for ELZONRIS (tagraxofusp-erzs) (Press release, Stemline Therapeutics, JAN 30, 2019, View Source [SID1234532956]). Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Stemline submitted the MAA earlier this month seeking approval of ELZONRIS for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the MAA was granted accelerated assessment.
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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.
ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with BPDCN. ELZONRIS is currently commercially available in the U.S.
"The validation of our MAA by the EMA represents another major step forward in our effort to provide patients with BPDCN in Europe access to ELZONRIS as expeditiously as possible," said Ivan Bergstein, M.D., Chief Executive Officer of Stemline Therapeutics. "With ELZONRIS now commercially available in the U.S., we remain committed to increasing access for patients with BPDCN who may benefit from ELZONRIS treatment, worldwide."
About BPDCN
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 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). For full prescribing information in the U.S., visit www.ELZONRIS.com. In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to, and validated by, 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 diseases.