Article(id=1291404905730793995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404875351449891, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.09.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1732291200000, receivedDateStr=2024-11-23, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824522668, onlineDateStr=2026-08-04, pubDate=1747411200000, pubDateStr=2025-05-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824522668, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824522668, creator=13701087609, updateTime=1785824522668, updator=13701087609, issue=Issue{id=1291404875351449891, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='9', pageStart='1201', pageEnd='1350', issueExtLink='null', onlineDate='null', pubDate='1747411200000', pubDateStr='2025-05-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824515426, creator='13701087609', updateTime=1785824515426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1319, endPage=1322, ext={EN=ArticleExt(id=1291404905986646541, articleId=1291404905730793995, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=New drug for the treatment of locally advanced or metastatic breast cancer: Inavolisib, columnId=1291339032068354347, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=New Drugs Introduction, runingTitle=null, highlight=null, articleAbstract=

Inavolisib is a kinase inhibitor that effectively and selectively inhibits the activity of p110α and promotes the degradation of mutant p110α. In October 2024, it was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic breast cancer that relapses during or after completion of adjuvant endocrine therapy. Inavolisib combined with palbociclib and fulvestrant can be used to treat locally advanced or metastatic breast cancers that are phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) mutation, hormone receptor (HR) positive, human epidermal growth factor receptor-2 (HER2) negative, and patient population has endocrine resistance characteristics. This combination therapy shows more significant antitumor efficacy than monotherapy inavolisib. This article reviews its mechanism of action, preclinical toxicology, pharmacokinetics, clinical research, etc.

, authors=Yu-shan NING^1a, Ting-ting LIU^1b, Wen-bin SHI^1c, An-jin CHEN^1d, authorsList=Yu-shan NING, Ting-ting LIU, Wen-bin SHI, An-jin CHEN, authorCompany=null, correspAuthors=Wen-bin SHI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404906351550990, articleId=1291404905730793995, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=治疗局部晚期或转移性乳腺癌新药——伊那利塞, columnId=1291339032219349293, journalTitle=中国临床药理学杂志, columnName=新药介绍, runingTitle=null, highlight=null, articleAbstract=

伊那利塞是一种激酶抑制药，可有效地选择性抑制磷脂酰肌醇3-激酶催化亚基p110α的活性，促进突变p110α的降解。2024年10月，经美国食品药品监督管理局（FDA）批准，用于治疗在辅助内分泌治疗期间或完成后复发的局部晚期或转移性乳腺癌。伊那利塞联合哌柏西利和氟维司群可用于治疗成人磷脂酰肌醇3-激酶催化亚基α（PIK3CA）突变、激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或转移性乳腺癌，患者群体具有内分泌抵抗性特征。与单药伊那利塞相比，这种联合治疗方案显示出更显著的抗肿瘤功效。本文对其作用机制、临床前毒理作用、药代动力学、临床研究等进行综述。

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宁宇杉（1975-），女，主管药师，主要从事医院药学相关研究

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宁宇杉（1975-），女，主管药师，主要从事医院药学相关研究

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