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FDA Medication Tracker

← All approvals · Cancer · 2024

Revuforj (revumenib)

The FDA approved Revuforj (revumenib) on November 15, 2024 to treat relapsed or refractory acute leukemia.
Brand name
Revuforj
Generic name
revumenib
FDA approval date
November 15, 2024
Approved use (FDA wording)
To treat relapsed or refractory acute leukemia
Company
Syndax
Application
NDA218944
Dosage form / route
TABLET · ORAL
Boxed warning on label
Yes (see the FDA label)
Category on this site
Cancer

Indications and usage, from the FDA label

REVUFORJ is a menin inhibitor 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. ( 1 ) 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. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.