Revumenib

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.

Revumenib achieved a 23% CR/CRh rate in relapsed/refractory NPM1-mutated AML, with 64% of responders showing negative MRD status. Syndax plans to file a supplemental NDA for NPM1-mutated AML in H1 2025, following potential FDA approval for KMT2A-rearranged leukemia.

The FDA approved revumenib (Revuforj) for relapsed/refractory acute leukemia with KMT2A translocation, based on AUGMENT-101 trial results showing 21.2% complete response rate and median response duration of 6.4 months. 40% of responders proceeded to allogeneic stem cell transplant.

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 data showing 21% CR+CRh rate. Safety evaluated in 135 patients, with common adverse reactions including hemorrhage and nausea.

FDA approves Revuforj, a menin inhibitor for relapsed or refractory acute leukemia with KMT2A translocation, showing 21% complete remission rate in 104 patients. Syndax plans to launch Revuforj in November, with 25 mg tablets available in 2025 for patients under 40 kg.

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

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation. AUGMENT-101 study showed 21.2% CR+CRh rate with median duration of 6.4 months. 14% of patients achieved transfusion independence. Common toxicities included hemorrhage, nausea, and musculoskeletal pain.

The FDA approved revumenib for relapsed/refractory acute leukemia with a KMT2A translocation, based on a trial showing a 21.2% CR+CRh rate and median duration of 6.4 months. Common adverse effects included hemorrhage, nausea, and musculoskeletal pain.