医学
达沙替尼
伊马替尼
主旨
酪氨酸激酶抑制剂
费城染色体
髓系白血病
酪氨酸激酶
肿瘤科
内科学
癌症研究
药理学
间质细胞
癌症
染色体易位
生物
生物化学
受体
基因
出处
期刊:Drugs
[Springer Nature]
日期:2022-02-23
卷期号:82 (4): 469-475
被引量:39
标识
DOI:10.1007/s40265-022-01680-9
摘要
Olverembatinib (HQP1351) is an oral, third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma for the treatment of chronic myeloid leukaemia (CML), acute myeloid leukaemia, acute lymphoblastic leukaemia (ALL) and solid tumours, including gastrointestinal stromal tumours (GIST). Olverembatinib is an ATP binding-site inhibitor of wild type BCR-ABL1 kinase and a broad spectrum of BCR-ABL1 mutants, including mutant T315I, which confers resistance against all first- and second-generation TKIs. In November 2021, olverembatinib received its first approval in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) harbouring the T315I mutation, as confirmed by a validated diagnostic test. Clinical studies are underway in the US for CML and precursor cell ALL, and in China for solid tumours, including GIST. This article summarizes the milestones in the development of olverembatinib leading to this first approval for the treatment of CML-CP or CML-AP.
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