Pharmacy Prior Authorization Criteria

Revuforj (revumenib)

Indications for Prior Authorization

Revuforj (revumenib)

• For diagnosis of Relapsed or Refractory Acute Leukemia
  Indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older.

• For diagnosis of Relapsed or Refractory Acute Myeloid Leukemia
  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.

Criteria

Revuforj

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• One of the following:
• Both of the following:
• Diagnosis of acute leukemia
AND
• Disease is confirmed by the presence of lysine methyltransferase 2A gene (KMT2A) translocation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• Both of the following:
• Diagnosis of acute myeloid leukemia (AML)
AND
• One of the following:
• Disease is confirmed by the presence of a lysine methyltransferase 2A gene (KMT2A) translocation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• Disease is confirmed by the presence of a susceptible nucleophosmin 1 (NPM1) mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Disease is relapsed or refractory
AND
• Patient is 1 year of age or older

Revuforj

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2026-06-23, 2025-12-26, 2025-12-08, 2025-04-14, 2024-12-24

References

1. Revuforj Prescribing Information. Syndax Pharmaceuticals, Inc. New York, NY. December 2025.

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Revision History

• 2026-06-23: Consolidated criteria buckets into one for all indications. Added KMT2A translocation as an option for AML genetic mutation.
• 2025-12-26: 2026 Annual Review: Update to standard genetic testing verbiage. Update references.
• 2025-12-08: For relapsed or refractory acute leukemia, updated indication verbiage and added genetic testing verbiage to mutation criterion. New indication for relapsed or refractory acute myeloid leukemia added, PA applied. Reference updated.
• 2025-04-14: Added Revuforj 25mg to guideline
• 2024-12-24: New Program.

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