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Drugs. 2017 Jul;77(11):1251-1259. doi: 10.1007/s40265-017-0779-0.
Midostaurin (Rydapt) is a multikinase inhibitor being developed by Novartis Pharmaceuticals. In April 2017, midostaurin was approved in the USA for the treatment of adult patients with newly diagnosed, FMS-like tyrosine kinase 3 (FLT3) mutation-positive acute myeloid leukaemia (AML) [in combination with standard cytarabine and daunorubicin induction, and cytarabine consolidation], or aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL) [collectively known as advanced SM]. The article summarizes the milestones in the development of midostaurin leading to this first global approval.
米哚妥林（Rydapt）是诺华制药公司开发的一种多激酶抑制剂。2017 年 4 月，米哚妥林在美国获得批准，用于治疗新诊断的、成纤维细胞生长因子受体酪氨酸激酶 3（FLT3）突变阳性的急性髓系白血病（AML）的成年患者[与标准阿糖胞苷和柔红霉素诱导及阿糖胞苷巩固联合治疗]，或侵袭性系统性肥大细胞增多症（ASM）、伴有血液肿瘤的系统性肥大细胞增多症（SM-AHN）或肥大细胞白血病（MCL）[统称为进展性 SM]。本文总结了米哚妥林开发过程中的重要里程碑，最终使其在全球范围内首次获得批准。
