Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for R/R Acute Leukemia
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Based on P-I/II (AUGMENT-101) study, the US FDA has approved Revuforj to treat r/r acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in individuals (age≥1yr.)
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In 104 efficacy evaluable patients, data showed CR + CRh was 21%, with median duration of 6.4mos. & median time to CR or CRh of 1.9mos.; 23% underwent HSCT post Revuforj.
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The company will release 110 & 160mg tablets in Nov across the US and 25mg tablets for patients with wt. <40kg in H1’25. An oral formulation will available under expanded access program for those with <40kg before the availability of 25mg tablets
Ref: Syndax | Image: Syndax
Related News:- Syndax Publishes the Pivotal AUGMENT-101 Study Data of Revumenib for R/R KMT2Ar Acute Leukemia in the Journal of Clinical Oncology
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
