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FDA grants priority review to Elzonris for blastic plasmacytoid dendritic cell neoplasm
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The FDA granted priority review designation to tagraxofusp for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm, according to the agent’s manufacturer.
Tagraxofusp (Elzonris, Stemline Therapeutics) is a CD123-directed novel therapy under investigation for this rare disease — an aggressive hematologic malignancy of the bone marrow and blood — as well as for chronic myelomonocytic leukemia and myelofibrosis. CD123 is a cell surface receptor expressed on a variety of malignancies.
Researchers successfully complete a pivotal trial of tagraxofusp among patients with blastic plasmacytoid dendritic cell neoplasm, according to the manufacturer.
The FDA also granted this application breakthrough therapy and orphan drug designations.
“The acceptance of our biologics license application for filing and grant of priority review represent tremendous milestones for Stemline and the blastic plasmacytoid dendritic cell neoplasm patient community,” Ivan Bergstein, MD, Stemline’s CEO, said in a press release. “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.”
The FDA set a target action date of Feb. 21.