IDHIFA enasidenib
Drug Class
IDH2 inhibitorIDH2 抑制剂
Mechanism
Inhibits mutant IDH2 proteins to decrease 2-hydroxyglutarate (2-HG) levels and restore normal myeloid cell differentiation.抑制突变型 IDH2 蛋白以降低 2-羟基戊二酸 (2-HG) 的水平，并恢复正常的骨髓细胞分化。
Approved Indication
Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.用于治疗携带异柠檬酸脱氢酶-2 (IDH2) 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
Idhifa (enasidenib) is a small-molecule targeted therapy indicated for relapsed or refractory acute myeloid leukemia (AML) harboring IDH2 mutations. It functions by allowing immature leukemia cells to differentiate into mature functional cells. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.恩西地平（Idhifa）是一种小分子靶向药物，适用于治疗携带 IDH2 突变的复发或难治性急性髓系白血病 (AML)。它通过促使未成熟的白血病细胞分化为成熟的有功能细胞来发挥作用。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 (2017) — label
Pivotal Clinical Evidence
- AG221-C-001 — Stein et al., Blood 2017 (NCT01915498) — 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.