Syndax receives FDA approval for Revuforj as first menin inhibitor for KMT2A-translocated acute leukemia

Syndax Pharmaceuticals Inc

FDA approved Revuforj for R/R acute leukemia with KMT2A translocation in patients aged 1+ years.
Efficacy: CR+CRh rate 21% (22/104), median duration 6.4 months, median time to remission 1.9 months.
Safety: common AEs include hemorrhage, febrile neutropenia, differentiation syndrome; 12% discontinued.
Commercial launch of 110/160 mg tablets expected Nov 2024; 25 mg tablets in early 2025.
SyndAccess patient support program launched; oral solution available via expanded access for patients <40 kg.

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