[Fda Approved Stamp]
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* The US FDA has approved Syndax Pharmaceuticals' (NASDAQ:SNDX [https://seekingalpha.com/symbol/SNDX]) Revuforj (revumenib) for relapsed or refractory acute myeloid leukemia in patients with a certain genetic mutation.
* The indication [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation] is for individuals with the disease who have the susceptible nucleophosmin 1 (_NPM1_) mutation and no other treatment options.
* Revuforj was first approved in 2024 for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation.
* The menin inhibitor's new indication was granted based on results from a single-arm cohort of an open-label trial. The complete remission with partial hematological recovery rate was 23.1% and the median duration was 4.5 months.
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Syndax gains additional indication for Revuforj in acute myeloid leukemia
Published 2 weeks ago
Oct 24, 2025 at 5:53 PM
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