Revumenib

Syndax Pharmaceuticals announced FDA approval of Revuforj (revumenib) for relapsed or refractory acute leukemia in patients with KMT2A translocation. Revuforj, the first FDA-approved menin inhibitor, targets KMT2A gene rearrangements. It showed 21% complete remission in AUGMENT-101 trial, with common adverse reactions including infection and hemorrhage. The drug will be available in 110 mg and 160 mg tablets, priced at $39,500 for a 30-day supply.

The FDA approved revumenib for treating advanced acute leukemia in patients with relapsed or refractory disease and a KMT2A gene translocation, based on AUGMENT-101 trial data showing a 21.2% CR+CRh rate and median CR+CRh duration of 6.4 months.

FDA approves Revuforj® (revumenib), the first menin inhibitor for treating R/R acute leukemia with KMT2A translocation in adult and pediatric patients. Based on AUGMENT-101 trial data, Revuforj showed 21% CR+CRh rate and 6.4-month median duration of remission. Syndax to launch Revuforj in November, with 25 mg tablets available in Q1-Q2 2025.

FDA approved revumenib, a menin inhibitor, for treating relapsed/refractory acute leukemia with KMT2A translocation in patients aged one and older. Supported by AUGMENT-101 trial data, it offers durable responses, enabling curative treatments like stem cell transplantation, despite common adverse events.

FDA approves Revuforj® (revumenib), the first menin inhibitor for R/R acute leukemia with KMT2A translocation in adult and pediatric patients. Efficacy based on AUGMENT-101 trial showing 21% CR+CRh rate. Safety profile includes common adverse reactions like hemorrhage and nausea.

The FDA approved revumenib for relapsed or refractory acute leukemia with a KMT2A translocation, based on the AUGMENT-101 trial. The drug showed a CR+CRh rate of 21.2% and was generally well-tolerated, with data to be presented at the 2024 ASH Annual Meeting.

The FDA approved Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with a KMT2A translocation, based on the AUGMENT-101 trial results. The trial showed 21.2% achieved complete remission plus complete remission with partial hematological recovery, with a median duration of 6.4 months. Common side effects included nausea, bleeding, and musculoskeletal pain.

The FDA approved revumenib (SNDX-5613) for relapsed/refractory KMT2A-rearranged acute leukemia, supported by AUGMENT-101 trial data showing 21.2% CR/CRh rate. Revumenib is the first Menin inhibitor for this condition, offering hope to patients with poor prognosis.