FDA Approves Revuforj for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation
Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Revuforj. The New Drug Application (NDA) received approval through the FDA’s Real Time Oncology Review (RTOR) program.
- Syndax expected that the 110 and 160mg tablets of Revuforj will be available for order in the United States through a network of specialty distributors and specialty pharmacies in November. Syndax expected that the 25mg tablets, which may be used to treat patients who weigh less than 40kg, will be commercially available in the late first quarter or early second quarter of 2025.
- Prior to commercial availability of the 25mg tablets, an oral solution of revumenib will be available through an expanded access program to allow for dosing of patients who weigh less than 40kg.
Source: Syndax Pharmaceuticals, Inc.
