Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	t(KMT2A;v)	Acute Lymphoblastic Leukemia	Revumenib
FDA (2)	t(KMT2A;v)	Acute Myeloid Leukemia	Revumenib
FDA (2)	t(KMT2A;v)	Burkitt Lymphoma	Revumenib
FDA (2)	t(KMT2A;v)	Acute Leukemias of Ambiguous Lineage	Revumenib

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2024-11-15	Food and Drug Administration	Indication received traditional approval.