Bosutinib (BOSULIF^®), an orally administered BCR–ABL tyrosine kinase inhibitor (TKI) developed by Pfizer Inc., is well established in the EU and the USA as a treatment for adults with newly diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), and for CP, accelerated phase and blast phase Ph+ CML that is resistant or intolerant (R/I) to prior therapy. In September 2023, based on clinical data from patients aged ≥ 1 to < 18 years, bosutinib was approved in the USA for the Query Text="Kindly check and confirm the processed article note" treatment of pediatric patients aged ≥ 1 year with CP Ph+ CML that is ND or R/I to prior therapy. This article summarizes the milestones in the development of bosutinib leading to this first pediatric approval.

博舒替尼 (BOSULIF ^® ) 是由辉瑞公司开发的一种口服 BCR-ABL 酪氨酸激酶抑制剂 (TKI)，在欧盟和美国已广泛用于治疗新诊断 (ND) 慢性期 (CP) 成人患者染色体阳性 (Ph+) 慢性粒细胞性白血病 (CML)，以及对先前治疗耐药或不耐受 (R/I) 的 CP、加速期和急变期 Ph+ CML。2023年9月，基于年龄≥1岁至<18岁患者的临床数据，博舒替尼在美国获批用于治疗≥1岁CP Ph+儿童患者CML 对先前的治疗为 ND 或 R/I。本文总结了博舒替尼开发过程中的里程碑，导致其首次获得儿科批准。