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Stemline Therapeutics' rare cancer drug gets US FDA priority review


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Stemline Therapeutics' rare cancer drug gets US FDA priority review

The U.S. Food and Drug Administration accepted and granted priority review to Stemline Therapeutics Inc.'s biologics license application for Elzonris to treat a rare type of cancer.

The drug also received FDA's breakthrough therapy and orphan drug designations.

Elzonris, also known as tagraxofusp and SL-401, is a potential treatment of blastic plasmacytoid dendritic cell neoplasm, or BPDCN, a rare form of blood and bone marrow cancer that affects multiple organs, including the lymph nodes and the skin.

BPDCN often presents with symptoms similar to acute myeloid leukemia, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia and other malignancies with skin manifestations.

Stemline's application was given a target action date of Feb. 21, 2019.

The New York-based company is also evaluating Elzonris in patients with chronic myelomonocytic leukemia, a type of cancer that develops in blood-forming cells of the bone marrow and invades the blood; myelofibrosis, a bone marrow disorder that disrupts the body's normal production of blood cells; and others.