Revuforj (revumenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Syndax Pharmaceuticals, Inc. Revuforj (revumenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.pdf. Revised November 2024. Accessed October 6, 2026.

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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	t(KMT2A;v)	Acute Lymphoblastic Leukemia	Revumenib
FDA (1)	t(KMT2A;v)	Acute Myeloid Leukemia	Revumenib
FDA (1)	t(KMT2A;v)	Burkitt Lymphoma	Revumenib
FDA (1)	t(KMT2A;v)	Acute Leukemias of Ambiguous Lineage	Revumenib