Enasidenib: First Global Approval
Enasidenib: First Global Approval
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DOI：
10.1007/s40265-017-0813-2
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发表时间：
2017-10-01
期刊：
影响因子：
11.5
通讯作者：
Kim, Esther S.
中科院分区：
文献类型：
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作者：
Kim, Esther S.
Enasidenib（Idhifa（R））是一种口服异柠檬酸脱氢酶-2（IDH 2）抑制剂，由Celgene Corporation根据Agios Pharmaceuticals的全球独家许可开发。Enasidenib已在美国被批准用于治疗患有复发性或难治性急性髓性白血病（AML）和IDH 2突变的成人（通过FDA批准的测试检测）。在其他国家，AML、骨髓增生异常综合征和实体瘤正处于不同的发展阶段。本文总结了enasidenib开发的里程碑，导致美国首次全球批准用于治疗复发性或难治性IDH 2突变AML成人。
Enasidenib (Idhifa (R)) is an oral isocitrate dehydrogenase-2 (IDH2) inhibitor developed by Celgene Corporation under a global, exclusive license from Agios Pharmaceuticals. Enasidenib has been approved in the USA for the treatment of adults with relapsed or refractory acute myeloid leukaemia (AML) and an IDH2 mutation as detected by an FDA-approved test. It is at various stages of development in other countries for AML, myelodysplastic syndromes and solid tumours. This article summarizes the milestones in the development of enasidenib leading to this first global approval in the USA for the treatment of adults with relapsed or refractory IDH2-mutated AML.