Revumenib (Revuforj)

Key facts

• Revuforj is not a general leukemia treatment; the FDA indications require specified KMT2A or NPM1 alterations.
• The KMT2A-translocated indication was approved in November 2024 for adults and children 1 year and older with relapsed or refractory acute leukemia.
• A second indication was approved in October 2025 for specified relapsed or refractory NPM1-mutated acute myeloid leukemia.
• The FDA label contains boxed warnings for differentiation syndrome and QTc prolongation with Torsades de Pointes.

What Revuforj is approved to treat

The first FDA approval covered relapsed or refractory acute leukemia with a KMT2A translocation in adult and pediatric patients 1 year and older.

The later approval covered relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

Important safety context

The current FDA prescribing information warns that differentiation syndrome can be fatal. It also warns about QTc prolongation and Torsades de Pointes and describes monitoring, dose changes, and drug interactions.

This summary is not a dosing guide. The current FDA label and the treating leukemia team should be used for patient-specific decisions.

Primary sources

• FDA: Revuforj approval for KMT2A-translocated acute leukemia — FDA approval notification dated November 15, 2024.
• FDA: Revuforj approval for NPM1-mutated acute myeloid leukemia — FDA approval notification dated October 24, 2025.
• FDA: Revuforj prescribing information — FDA label with current indications, boxed warnings, dosing, interactions, and adverse reactions.