Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that t(KMT2A;v) status confers therapeutic sensitivity to Revumenib in patients with Burkitt Lymphoma.

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.