Kennametal(KMT) Prnewswire·2024-11-15 22:29Core Insights - The FDA has approved Revuforj® (revumenib) as the first menin inhibitor for treating relapsed or refractory acute leukemia with a KMT2A translocation in patients aged one year and older [1][2][3] - The approval is based on positive data from the AUGMENT-101 clinical trial, demonstrating a 21% complete remission rate among treated patients [2][3] - Syndax Pharmaceuticals is preparing to launch Revuforj and is committed to advancing its development for KMT2A-rearranged acute leukemias and mutant NPM1 AML [2][8] Efficacy and Safety - In the AUGMENT-101 trial, 104 patients were evaluated, with a complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 21% [2] - The median duration of CR+CRh was 6.4 months, and the median time to CR or CRh was 1.9 months [2] - The safety evaluation involved 135 patients, with common adverse reactions including hemorrhage (53%), nausea (51%), and infection (41%) [3][18] Market Availability - Revuforj tablets (110 mg and 160 mg) are expected to be available for order in the U.S. in November 2024, with 25 mg tablets anticipated in early 2025 [4] - An oral solution of revumenib will be available through an expanded access program for patients weighing less than 40 kg prior to the commercial availability of the 25 mg tablets [4] Company Commitment - Syndax has established SyndAccess™, a program providing personalized support and financial assistance to U.S. patients prescribed Revuforj [5] - The company is focused on removing barriers to access for patients and enhancing support resources [5] Future Developments - Revumenib is also in development for treating R/R acute myeloid leukemia (AML) with a nucleophosmin 1 mutation (mNPM1), with ongoing trials in combination with standard-of-care agents [8][9] - The company is conducting multiple clinical trials across the treatment landscape for KMT2A-rearranged acute leukemia and mNPM1 AML [8][22]