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FDA grants fast track designation to oral KAT2A/B degrader AUTX-703 in R/R AML
On February 24, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation to AUTX-703, a first-in-class oral KAT2A/B degrader, for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML).1
Preclinical studies found that AUTX-703 selectively and strongly degrades KAT2A/B, reversing the block in cellular differentiation and improving survival in primary patient AML cells.2 AUTX-703 has received investigational new drug clearance from the FDA, with a phase I clinical trial expected to begin in Q1 2025.1,3
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