Syndax confirms FDA approves second indication for Revuforj

Syndax (SNDX) Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Revuforj for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Revuforj previously received FDA approval in 2024 for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. Revuforj is the first and only FDA-approved therapy for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation. “We are thrilled to have secured a second indication for Revuforj, making it the first and only menin inhibitor that is FDA-approved for multiple acute leukemia subtypes in both adults and children. The breadth of the indicated patient population highlights the compelling and consistent efficacy and tolerability of Revuforj in multiple different types of patients. Our launch into this second population will greatly benefit from physicians’ already strong familiarity with Revuforj and positive experience treating well over 1,000 patients in clinical trials and nearly one year of commercial use. I would like to thank everyone who made this approval possible, especially the patients and clinicians who participated in our trial and our dedicated Syndax team. We will continue to innovate for patients with menin-dependent acute leukemias and look forward to leading the development of this exciting new therapeutic class into the frontline,” said Michael Metzger, Chief Executive Officer.