Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that NPM1 p.W288Cfs*12 status confers therapeutic sensitivity to Revumenib in patients with Acute Myeloid Leukemia.

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 myeloid leukemia and a susceptible .nucleophosmin 1 (NPM1) variant. The approval defines susceptible NPM1 mutations as those that result in a loss of the nucleolar localization signal and the insertion of a new nuclear export signal leading to the accumulation of mutant NPM1 in the cytoplasm of AML cells; the most common of such NPM1 variants in patients with AML being Types A (c.860_863dupTCTG), B (c.863_864insCATG), and D (c.863_864insCCTG).

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 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.

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/2025/218944s003lbl.pdf. Revised October 2025. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2025-12-26 Van Allen lab On 2025-10-24, the US FDA granted approval to revumenib for the treatment of adult and pediatric patients 1 year or older who have no satisfactory alternative treatment options with relapsed or refractory acute myeloid leukemia and a susceptible NPM1 variant.
2025-10-24 Food and Drug Administration Indication received traditional approval.