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Drugs. 2017 Oct;77(15):1705-1711. doi: 10.1007/s40265-017-0813-2.
Enasidenib (Idhifa) 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.
依鲁替尼（Idhifa）是一种口服异柠檬酸脱氢酶-2（IDH2）抑制剂，由 Celgene 公司在 Agios 制药公司的全球独家许可下开发。依鲁替尼已获得美国批准，用于治疗经 FDA 批准的检测方法检出的 IDH2 突变的复发性或难治性急性髓细胞白血病（AML）成人患者。该药目前在其他国家处于 AML、骨髓增生异常综合征和实体瘤的不同开发阶段。本文总结了依鲁替尼开发过程中的重要里程碑，最终该药在美国获得了首个全球批准，用于治疗复发性或难治性 IDH2 突变型 AML 成人患者。
