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FDA grants fast track designation for 4A10 in ALL
The U.S. Food and Drug Administration (FDA) has granted fast track designation for 4A10 for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL). 4A10 is a monoclonal antibody targeting the interleukin-7 receptor alpha (IL-7Rα; CD127); it inhibits IL-7 signaling and induces antibody-dependent cellular cytotoxicity and phagocytosis, resulting in targeted elimination of leukemic cells.
Orphan drug designation and rare pediatric disease designation were previously granted by the FDA for 4A10 in ALL. The fast track designation builds on the FDA clearance of the investigational new drug application for 4A10 in ALL. Preclinical studies showed promising anti-leukemic activity and a favorable safety profile of 4A10, supporting advancement into a first-in-human clinical trial for patients with R/R ALL.
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