UPDATE 2-U.S. FDA approves Stemline Therapeutics' rare blood disease treatment [Reuters]
STEMLINE THERAPEUTICS (STML)
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Source: Reuters
U.S. FDA approves Stemline Therapeutics' rare blood disease treatment | Reuters 2 Min Read (Reuters) - The U.S. Food and Drug Administration on Friday approved Stemline Therapeutics Inc’s Elzonris for the treatment of a rare blood disease in adults and children aged two years and above. This is the first approved treatment for the condition, blastic plasmacytoid dendritic cell neoplasm (BPDCN), Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said. Elzonris will be commercially available in early 2019, the company said. The labeling for Elzonris contains a boxed warning, FDA’s harshest, flagging increased risk of capillary leak syndrome, which may be life-threatening or fatal to patients in treatment. Last year, the drug developer said a patient death had occurred in the clinical studies of Elzonris, after developing capillary leak syndrome, a “well-documented side effect” of the drug. “Boxed warning should have been expected given the history of capillary leak syn
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