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FDA Brief: SNDX-5613 Receives Fast Track Designation for Certain Resistant Acute Leukemias

By: JNCCN 360 Staff
Posted: Wednesday, July 7, 2021

On June 28, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral menin-MLL (mixed lineage leukemia) inhibitor SNDX-5613 for relapsed or refractory acute leukemias harboring an MLL-rearranged or nucleophosmin mutation (NPM1) in both adult and pediatric patients. SNDX-5613 was previously given Orphan Drug designation for the treatment of patients with AML and Fast Track designation for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring an MLL-rearranged or NPM1 mutation.

In preclinical models of MLL-rearranged acute leukemias, SNDX-5613 demonstrated dose-dependent inhibition of tumor growth, resulting in a survival benefit. SNDX-5613 is currently being evaluated in the open-label phase I/II AUGMENT-101 clinical trial for the treatment of relapsed or refractory acute leukemias.


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