美国食品和药物管理局批准Revuforj用于1岁及以上的NPM1突变AML患者. FDA approves Revuforj for NPM1-mutated AML in patients aged one and older.

美国食品和药物管理局批准了Revuforj (revumenib) 治疗复发或耐药的急性髓性白血病 (AML) 的成人和1岁及以上儿童,该药物携带NPM1突变,扩大了对KMT2A重组白血病的先前批准. The FDA has approved Revuforj (revumenib) for adults and children aged one year and older with relapsed or refractory acute myeloid leukemia (AML) harboring an NPM1 mutation, expanding its prior approval for KMT2A-rearranged leukemia. 该决定根据涉及241名病人的AUGOMT-101试验数据作出,显示有23.1%的完整反应或部分血解恢复率,中位反应期为4.5个月。 The decision, based on data from the AUGMENT-101 trial involving 241 patients, showed a 23.1% complete response or partial hematologic recovery rate, with a median response duration of 4.5 months. 该药物带有各种风险,包括差异综合症、QTc延长和胚胎毒性。 The drug carries risks including differentiation syndrome, QTc prolongation, and embryo-fetal toxicity. Syndax制药公司还启动了SyndAccessé,这是一个提供财务和病人援助的支助方案。 Syndax Pharmaceuticals also launched SyndAccess®, a support program offering financial and patient assistance.