On August 13, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Stemline Therapeutics, AUG 13, 2018, View Source [SID1234532233]). The FDA also granted Priority Review for the BLA and has set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).
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The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
ELZONRIS has also been granted Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) by the FDA.
Ivan Bergstein, M.D., Stemline’s CEO, commented, "The acceptance of our BLA for filing and grant of Priority Review represent tremendous milestones for Stemline and the BPDCN patient community. We would like to thank the patients and their families who participated in our clinical trials, as well as recognize the tireless work of our investigators and entire Stemline team. Given both Priority and Breakthrough status, our commercial organization is positioning itself to rapidly launch ELZONRIS, if approved, to ensure this important new treatment reaches patients as quickly as possible."
Conference Call and Webcast
Stemline Therapeutics will host a conference call and audio webcast on Monday, August 13, 2018 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing 844-389-8660 (U.S./Canada) or 478-219-0408 (International) and referencing conference ID: 4762319. An audio webcast can also be accessed via the Investor Relations tab of the Stemline Therapeutics website at View Source
About ELZONRISTM (tagraxofusp; SL-401)
ELZONRISTM (tagraxofusp; SL-401) is a novel targeted investigational therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. ELZONRIS successfully completed a pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and a Biologics License Application (BLA) in this indication has been accepted for filing and been granted Priority Review by the U.S. Food and Drug Administration (FDA). ELZONRIS has also been granted Breakthrough Therapy Designation (BTD) and Orphan Drug Designation by the FDA. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and others.