FDA approved revumenib for KMT2A-rearranged relapsed or refractory acute leukemia
The approval, dated November 15, 2024, covers adult and pediatric patients age 1 and older with relapsed or refractory disease carrying a KMT2A translocation.
On November 15, 2024, the FDA approved revumenib, sold under the brand name Revuforj by Syndax Pharmaceuticals, Inc., for relapsed or refractory acute leukemia in patients with a KMT2A gene translocation. The drug is a menin inhibitor approved for adult and pediatric patients 1 year and older whose acute leukemia carries a lysine methyltransferase 2A gene (KMT2A) translocation.1
The FDA's record identifies the approval as applying specifically to relapsed or refractory disease in this genetically defined patient population, spanning both adult and pediatric age groups starting at one year old.
No additional details on dosing, trial results, or clinical endpoints are included in the FDA record supplied.
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