Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that t(KMT2A;v) status confers therapeutic sensitivity to Revumenib in patients with Acute Leukemias of Ambiguous Lineage.

The U.S. Food and Drug Administration (FDA) granted approval to revumenib for the treatment of adult and pediatric patients 1 year and older with relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. 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.

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.