Regulatory approval

Published by the Food and Drug Administration. Approved

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.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) NPM1 p.W288Cfs*12 Acute Myeloid Leukemia Revumenib
FDA (1) NPM1 p.W288Cfs*12 Acute Lymphoid Leukemia Revumenib
FDA (1) NPM1 p.W288Cfs*12 Burkitt Lymphoma Revumenib
FDA (1) NPM1 p.W288Cfs*12 Acute Leukemias of Ambiguous Lineage Revumenib