Revuforj (revumenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Syndax Pharmaceuticals, Inc. Revuforj (revumenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218944s003lbl.pdf. Revised October 2025. Accessed December 26, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
REVUFORJ is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.	4
REVUFORJ is a menin inhibitor indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	t(KMT2A;v)	Acute Lymphoid Leukemia	Revumenib	FDA
Sensitivity (+)	t(KMT2A;v)	Acute Myeloid Leukemia	Revumenib	FDA
Sensitivity (+)	t(KMT2A;v)	Burkitt Lymphoma	Revumenib	FDA
Sensitivity (+)	t(KMT2A;v)	Acute Leukemias of Ambiguous Lineage	Revumenib	FDA
Sensitivity (+)	NPM1 p.W288Cfs*12	Acute Myeloid Leukemia	Revumenib	FDA
Sensitivity (+)	NPM1 p.W288Cfs*12	Acute Lymphoid Leukemia	Revumenib	FDA
Sensitivity (+)	NPM1 p.W288Cfs*12	Burkitt Lymphoma	Revumenib	FDA
Sensitivity (+)	NPM1 p.W288Cfs*12	Acute Leukemias of Ambiguous Lineage	Revumenib	FDA