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In May 2025, the U.S. Food and Drug Administration (FDA) accepted and granted priority review for the new drug application (NDA) for the oral human epidermal growth factor receptor 2 (HER2) inhibitor Sevabertinib (Hyrnuo, BAY 2927088), which was subsequently approved on November 19, 2025. Sevabertinib is a highly selective and reversible HER2 tyrosine kinase inhibitor indicated for adult patients with HER2-mutant advanced non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The launch of Sevabertinib provides a new oral targeted option for the adjuvant treatment of NSCLC. Clinical studies have demonstrated promising antitumor activity across different patient populations, with particularly high objective response rates (ORR) in patients without prior HER2-targeted therapy. The most common adverse events include diarrhea, hepatotoxicity, and interstitial lung disease, which are generally manageable. This review summarizes the mechanism of action, pharmacokinetics, clinical efficacy, safety profile, and drug interactions of Sevabertinib to support its rational clinical use.

, authors=Lu CAO, Wen-jing LI, authorsList=Lu CAO, Wen-jing LI, authorCompany=null, correspAuthors=Wen-jing LI, 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=1292130413296771358, articleId=1292130411459666204, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=治疗HER2突变型晚期非小细胞肺癌新药Sevabertinib, columnId=1291339032219349293, journalTitle=中国临床药理学杂志, columnName=新药介绍, runingTitle=null, highlight=null, articleAbstract=

2025年5月，美国食品药品监督管理局（FDA）受理口服人表皮生长因子受体2（HER2）抑制剂Sevabertinib的新药申请（NDA）并授予优先审评资格，该药于2025年11月19日获准上市。Sevabertinib是一种高选择性、可逆的HER2酪氨酸激酶抑制剂，适用于既往接受过系统治疗的HER2激活突变晚期非小细胞肺癌（NSCLC）成人患者。Sevabertinib的上市为NSCLC的辅助治疗提供了新的口服靶向选择。临床研究显示，Sevabertinib在不同治疗人群中均表现出良好的抗肿瘤活性，尤其在未接受HER2靶向治疗患者中客观缓解率（ORR）较高。其常见不良反应包括腹泻、肝毒性及间质性肺病等，总体安全性可控。本文从作用机制、药代动力学、临床疗效、不良反应及药物相互作用等方面对Sevabertinib进行系统综述，以期为临床合理用药提供参考。

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曹璐（1987-），女，主管药师，主要从事医院药学与临床药学的工作和研究

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曹璐（1987-），女，主管药师，主要从事医院药学与临床药学的工作和研究

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