SL-401 (Elzonris®, Tagraxofusp-erzs) is a CD123-directed cytotoxin first approved by the U.S. Food and Drug Administration on December 21 2018 and by the European Commission in January 2021.
Elzonris® is the first approved therapy for children and adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Clinical data that supported the first approval application was published in N Engl J Med.
The drug was first created with LLS grant support to Dr. Arthur Frankel of University of Texas Southwestern Medical Center. He showed this targeted therapy can produce durable complete responses in patients with BPDCN or with advanced AML.
The Leukemia & Lymphoma Society's Therapy Acceleration Program® (TAP) committed more than $3 million in a partnership with Stemline Therapeutics between 2013-2018 to advance the new therapy. The clinical study that led to approval by the FDA was supported in part by LLS TAP. Stemline was acquired by the Menarini Group in 2020.