Revumenib FDA Approval Status
Last updated by Judith Stewart, BPharm on April 10, 2024.
FDA Approved: No
Generic name: revumenib
Company: Syndax Pharmaceuticals, Inc.
Treatment for: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Revumenib is a first-in-class menin inhibitor in development for the treatment of relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1-mutant (NPM1m) AML.
- Menin is a scaffold protein, and its binding to KMT2A leads to transcriptional activation of leukemogenic genes such as HOX and MEIS1. Revumenib works to treat KMT2Ar acute leukemias by fitting into the binding pocket of menin and displacing KMT2A to turn off the HOX and MEIS genes and halt leukemic cell growth.
- Revumenib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with AML, and Fast Track designation by the FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. Revumenib was also granted Breakthrough Therapy Designation by the FDA for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.
- The FDA has granted Priority Review for the New Drug Application (NDA) for revumenib. The NDA filing is being reviewed under the FDA's Real-Time Oncology Review Program (RTOR) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024.
Development timeline for revumenib
Further information
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