Regulatory approval
Published by the Food and Drug Administration.
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 leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation.
This is written in the approval document as:
REVUFORJ is a 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.
Citation
Syndax Pharmaceuticals, Inc. Revuforj (revumenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.pdf. Revised November 2024. Accessed January 10, 2025.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | t(KMT2A;v) | Acute Lymphoid Leukemia | Revumenib | |
| Sensitivity (+) | t(KMT2A;v) | Acute Myeloid Leukemia | Revumenib | |
| Sensitivity (+) | t(KMT2A;v) | Burkitt Lymphoma | Revumenib | |
| Sensitivity (+) | t(KMT2A;v) | Acute Leukemias of Ambiguous Lineage | Revumenib |