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Stemline Therapeutics Announces that European Medicines Agency (EMA) Grants Accelerated Assessment for planned ELZONRIS Marketing Authorization Application (MAA)
NEW YORK, Nov. 20, 2018 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, announced today 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 ELZONRISTM (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 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.”
Please visit the BPDCN disease awareness booth (#205) at ASH 2018, and the BPDCN disease awareness website at www.bpdcninfo.com.
About Stemline Therapeutics
Stemline Therapeutics, Inc. is a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics. Stemline is developing three clinical stage product candidates, ELZONRISTM (tagraxofusp; SL-401), SL-801, and SL-701. ELZONRIS is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a range of malignancies. ELZONRIS has successfully completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), for which it was granted breakthrough therapy designation (BTD). A Biologics License Application (BLA) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The European Medicines Agency (EMA) has granted ELZONRIS accelerated assessment for the upcoming marketing authorization application (MAA) submission, which is expected in the first quarter of 2019. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and others. SL-801 is a novel oral small molecule reversible inhibitor of XPO1 that is currently in a Phase 1 trial of patients with advanced solid tumors; dose escalation is ongoing. SL-701, an immunotherapeutic, has completed a Phase 2 trial in patients with second-line glioblastoma; data and next steps for the program are being evaluated.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our BLA submission to the FDA; the success and timing of our MAA submission to the EMA CHMP; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA, EMA, or other ex-U.S. national drug authority ultimately does not agree with our data, find our data supportive of approval, or approve any of our product candidates; the possibility that results of clinical trials are not predictive of safety and efficacy results of our product candidates in broader patient populations or of our products if approved; our plans to develop and commercialize our product candidates; the risk that estimates regarding the number of patients with the diseases that our product candidates may treat are inaccurate; our products not gaining acceptance among patients (and providers or third party payers) for certain indications (due to cost or otherwise); the adequacy of our pharmacovigilance and drug safety reporting processes; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; delays, interruptions, or failures in the manufacture and supply of our product candidates; the performance of third-party businesses, including, but not limited to, manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Stemline Therapeutics, Inc.
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