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U.S. FDA grants fast track designation to HC-7366 for the treatment of R/R AML
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On October 23, 2024, the U.S. Food and Drug Administration (FDA) granted fast track designation to HC-7366, a first-in-class small molecule activator of the general control nonderepressible 2 (GCN2) kinase, for the treatment of adult patients with relapsed/refractory (R/R) acute myeloid leukemia (AML).1
HC-7366 is currently being investigated in combination with venetoclax plus azacitidine in an ongoing phase Ib trial (NCT06285890) to evaluate its recommended phase II dose, safety, tolerability, and preliminary efficacy in patients with R/R AML or myelodysplastic syndrome/AML with 10% to 19% blasts. Based on findings from the dose-escalation part, other combinations and monotherapy cohorts may be explored.1
- GlobeNewswire. HiberCell Receives FDA Fast Track Designation for HC-7366 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML).
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