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.