Revuforj FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 18, 2024.
FDA Approved: Yes (First approved November 15, 2024)
Brand name: Revuforj
Generic name: revumenib
Dosage form: Tablets
Company: Syndax Pharmaceuticals, Inc.
Treatment for: Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Revuforj (revumenib) is a first-in-class 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.
- Rearrangements of the KMT2A gene (KMT2Ar) give rise to an aggressive form of acute leukemia that is associated with a very poor prognosis and high relapse rates. The KMT2Ar genetic abnormality is found in about 10% of acute leukemias.
- Revuforj works to treat KMT2Ar acute leukemias by blocking the interaction of both wild-type lysine methyltransferase 2A (KMT2A) and KMT2A fusion proteins with menin, a scaffold protein that controls gene expression and cell signaling.
- FDA approval of Revuforj was based on positive data from the AUGMENT-101 clinical trial of 104 patients with relapsed or refractory (R/R) acute leukemia with a KMT2A translocation. The rate of complete remission plus complete remission with partial hematological recovery (CR+CRh) was 21.2%, the median duration of CR+CRh was 6.4 months, and the median time to CR or CRh was 1.9 months.
- Revuforj tablets are administered orally, twice daily, fasted or with a low-fat meal.
- Revuforj carries a Boxed Warning for differentiation syndrome, which can be fatal. Warnings and precautions associated with Revuforj include QTc interval prolongation and embryo-fetal toxicity.
- Common adverse reactions (≥ 20%) include hemorrhage, nausea, musculoskeletal pain, infection, febrile neutropenia, bacterial infection, diarrhea, differentiation syndrome, QTc interval prolongation, decreased appetite, constipation, edema, viral infection, and fatigue.
Common laboratory abnormalities include increased phosphate, increased aspartate aminotransferase, increased alanine aminotransferase, increased intact parathyroid hormone, decreased phosphate, increased triglycerides, decreased potassium, and increased alkaline phosphatase.
Development timeline for Revuforj
Further information
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