Shots:   

• 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.)  

• 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. 

• 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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