Rezlidhia olutasidenib
Drug Class
IDH1 inhibitorIDH1 抑制剂
Mechanism
Inhibits mutant IDH1 to prevent the accumulation of 2-hydroxyglutarate (2-HG), inducing differentiation of myeloblasts.抑制突变型 IDH1 以阻止 2-羟基戊二酸 (2-HG) 的积累，并诱导骨髓造血原细胞发生分化。
Approved Indication
Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.用于治疗携带易感异柠檬酸脱氢酶-1 (IDH1) 突变的复发或难治性急性髓系白血病 (AML) 成人患者。
What This Means For Patients
Rezlidhia (olutasidenib) is an oral IDH1 inhibitor developed for patients with relapsed or refractory acute myeloid leukemia (AML) carrying IDH1 mutations. It promotes cancer cells to mature into normal white blood cells. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.奥鲁萨替尼（Rezlidhia）是一种口服 IDH1 抑制剂，用于治疗携带 IDH1 突变的复发或难治性急性髓系白血病 (AML) 患者。它能促使癌细胞分化成熟为正常白细胞。该药物已通过先行区特许进口政策引入博鳌乐城。
Regulatory Approvals
- FDA — approved (2022) — label
Pivotal Clinical Evidence
- 2102-HEM-101 — de Botton et al., Blood Adv 2023 (NCT02719574) — DOI
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.