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FDA Approves Revuforj® as First Menin Inhibitor for Acute Leukemia with KMT2A Translocation

NextEdge Admin

17 Nov 2024

2 min 21 sec

Syndax Pharmaceuticals announced FDA approval of Revuforj® (revumenib), the first menin inhibitor for treating relapsed or refractory (R/R) acute leukemia with KMT2A translocation in patients aged one year and older. This approval, granted through the FDA’s Real-Time Oncology Review (RTOR) program, follows Breakthrough Therapy, Fast Track, and Priority Review designations.

The efficacy of Revuforj was evaluated in 104 patients from the Phase 1/2 AUGMENT-101 trial. Among these, 21% achieved complete remission (CR) or CR with partial hematological recovery (CRh), with a median duration of 6.4 months. The median time to response was 1.9 months. Additionally, 23% of patients underwent hematopoietic stem cell transplantation after treatment.

Revuforj addresses an unmet need for KMT2A-rearranged acute leukemia, a highly aggressive form with poor prognosis and high relapse rates. Conventional therapies result in a median survival of less than one year, with significantly lower outcomes in later-line settings.

Safety data from 135 patients indicated common adverse reactions, including nausea, infection, musculoskeletal pain, and differentiation syndrome, with low rates of dose reduction (10%) or permanent discontinuation (12%).

Syndax plans to launch 110 mg and 160 mg Revuforj tablets in November 2024 through specialty distributors, with 25 mg tablets for smaller patients available by mid-2025. An oral solution will support expanded access for younger patients until tablet availability.

CEO Michael Metzger emphasized Syndax’s commitment to advancing Revuforj for KMT2Ar acute leukemias, calling it a pivotal step for patients with limited treatment options.