Blair Hannah A
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2025 Feb;85(2):271-278. doi: 10.1007/s40265-024-02136-y. Epub 2025 Jan 28.
Inavolisib (Itovebi) is an orally administered, phosphatidylinositol-3-kinase alpha (PI3Kα) inhibitor being developed by Genentech, a member of the Roche group, for the treatment of solid tumours. On 10 October 2024, inavolisib received its first approval in the USA in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. In the EU and other countries worldwide, regulatory review of inavolisib is currently underway. This article summarises the milestones in the development of inavolisib leading to this first approval for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.
阿那沃利西布（Itovebi）是一种口服的磷脂酰肌醇-3-激酶α（PI3Kα）抑制剂，由罗氏集团成员基因泰克公司研发，用于治疗实体瘤。2024年10月10日，阿那沃利西布在美国首次获批，与哌柏西利和氟维司群联合用于治疗经美国食品药品监督管理局（FDA）批准的检测方法检测出的、在内分泌辅助治疗期间或之后复发的、具有内分泌抵抗性、PIK3CA突变、激素受体（HR）阳性、人表皮生长因子2（HER2）阴性、局部晚期或转移性乳腺癌的成年患者。在欧盟和世界其他国家，阿那沃利西布的监管审评目前正在进行中。本文总结了阿那沃利西布在研发过程中取得的里程碑事件，这些事件促成了其首次获批用于治疗内分泌抵抗性、PIK3CA突变、HR阳性、HER2阴性、局部晚期或转移性乳腺癌。
