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# Syndax Reports ‘Positive’ Leukemia Data
- URL: https://www.fdaweb.com/syndax-reports-positive-leukemia-data/
- Published: 2023-10-06T12:00:00.000Z
- Updated: 2026-09-14T19:01:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155510

Syndax Pharmaceuticals says new positive data warrants stopping the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia. The decision to stop the trial is based on a recommendation from the company’s independent data monitoring committee following a protocol-defined pooled analysis that showed the trial met its primary endpoint with a complete remission (CR) or a CR with partial hematological recovery rate of 23%, the company says. In the efficacy-evaluable patients, the overall response rate was 63%, it adds. Syndax says it plans to file an NDA by year-end.