奥鲁司他尼：首次获批。
Olutasidenib: First Approval.
作者信息
Kang Connie
机构信息
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
出版信息
Drugs. 2023 Mar;83(4):341-346. doi: 10.1007/s40265-023-01844-1.
Olutasidenib (REZLIDHIA), an isocitrate dehydrogenase-1 (IDH1) inhibitor, is being developed by Rigel Pharmaceuticals for the treatment of relapsed or refractory (R/R) acute myeloid leukaemia (AML). Olutasidenib was recently approved in the USA for the treatment of adults with R/R AML with a susceptible IDH1 mutation as detected by a US Food and Drug Administration-approved test. This article summarizes the milestones in the development of olutasidenib leading to this first approval for R/R AML.
奥鲁索丹（REZLIDHIA）是一种异柠檬酸脱氢酶-1（IDH1）抑制剂，由里吉尔制药公司研发，用于治疗复发或难治性（R/R）急性髓系白血病（AML）。奥鲁索丹最近在美国获批，用于治疗经美国食品药品监督管理局批准的检测方法检测出具有敏感IDH1突变的R/R AML成人患者。本文总结了奥鲁索丹研发过程中的重要节点，这些节点促成了其在R/R AML治疗上的首次获批。
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