Revumenib

The FDA approved revumenib (Revuforj) for treating acute leukemia in patients 1 year and older, targeting KMT2A gene changes. A clinical trial showed 21% achieved complete remission lasting 6.5 months, with common side effects including bleeding and infections. 110-mg and 160-mg tablets will be available this month, with a liquid solution for patients under 40 kg available through an Expanded Access Program.

FDA approved Revuforj (revumenib), a menin inhibitor developed by Syndax, for treating relapsed or refractory acute leukemia with a KMT2A gene translocation in adults and pediatric patients. The approval was based on the AUGMENT-101 trial results, with 110 and 160 mg tablets expected to be available in November. Syndax also entered a $350 million royalty funding agreement for Niktimvo with Royalty Pharma.

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 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.