唑贝妥昔单抗：首次获批。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2024-08-01 Epub Date: 2024-07-05 DOI:10.1007/s40265-024-02056-x

Susan J Keam

{"title":"唑贝妥昔单抗：首次获批。","authors":"Susan J Keam","doi":"10.1007/s40265-024-02056-x","DOIUrl":null,"url":null,"abstract":"Zolbetuximab (VYLOY™), a recombinant, chimeric, anti-claudin 18.2 (CLDN18.2) monoclonal antibody (mAb), is being developed by Astellas Pharma Inc. for the treatment of patients with HER2-negative (HER2-), CLDN18.2-positive (CLDN18.2+) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and CLDN18.2+ advanced pancreatic adenocarcinoma. In March 2024, zolbetuximab was approved in Japan for the treatment of patients with HER2-, CLDN18.2+ unresectable, advanced/recurrent gastric cancer (the gastric cancer indication includes GEJ cancer). Zolbetuximab is also undergoing regulatory review for HER2-, CLDN18.2+ advanced gastric or GEJ adenocarcinoma in the USA, the EU, China, Australia and several other countries. This article summarizes the milestones in the development of zolbetuximab leading to this first approval for the treatment of patients with CLDN18.2+ gastrointestinal malignancies.","PeriodicalId":11482,"journal":{"name":"Drugs","volume":null,"pages":null},"PeriodicalIF":13.0000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Zolbetuximab: First Approval.\",\"authors\":\"Susan J Keam\",\"doi\":\"10.1007/s40265-024-02056-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Zolbetuximab (VYLOY™), a recombinant, chimeric, anti-claudin 18.2 (CLDN18.2) monoclonal antibody (mAb), is being developed by Astellas Pharma Inc. for the treatment of patients with HER2-negative (HER2-), CLDN18.2-positive (CLDN18.2+) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and CLDN18.2+ advanced pancreatic adenocarcinoma. In March 2024, zolbetuximab was approved in Japan for the treatment of patients with HER2-, CLDN18.2+ unresectable, advanced/recurrent gastric cancer (the gastric cancer indication includes GEJ cancer). Zolbetuximab is also undergoing regulatory review for HER2-, CLDN18.2+ advanced gastric or GEJ adenocarcinoma in the USA, the EU, China, Australia and several other countries. This article summarizes the milestones in the development of zolbetuximab leading to this first approval for the treatment of patients with CLDN18.2+ gastrointestinal malignancies.\",\"PeriodicalId\":11482,\"journal\":{\"name\":\"Drugs\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":13.0000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drugs\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40265-024-02056-x\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/5 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-024-02056-x","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/5 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

唑贝妥昔单抗（VYLOY™）是一种重组嵌合型抗克劳丁18.2（CLDN18.2）单克隆抗体（mAb），由安斯泰来制药公司开发，用于治疗HER2-阴性（HER2-）、CLDN18.2阳性（CLDN18.2+）晚期胃癌或胃食管交界处（GEJ）腺癌和CLDN18.2+晚期胰腺癌患者。2024 年 3 月，唑贝妥昔单抗在日本获批用于治疗 HER2-、CLDN18.2+ 不可切除的晚期/复发性胃癌患者（胃癌适应症包括 GEJ 癌）。在美国、欧盟、中国、澳大利亚和其他一些国家，唑贝妥昔单抗也正在接受针对HER2-、CLDN18.2+晚期胃癌或胃食管腺癌的监管审查。本文总结了唑贝妥昔单抗开发过程中的里程碑事件，这些事件促成了唑贝妥昔单抗首次获批用于治疗CLDN18.2+胃肠道恶性肿瘤患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Zolbetuximab: First Approval.

查看原文本刊更多论文

Zolbetuximab: First Approval.

Zolbetuximab (VYLOY™), a recombinant, chimeric, anti-claudin 18.2 (CLDN18.2) monoclonal antibody (mAb), is being developed by Astellas Pharma Inc. for the treatment of patients with HER2-negative (HER2^-), CLDN18.2-positive (CLDN18.2⁺) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and CLDN18.2⁺ advanced pancreatic adenocarcinoma. In March 2024, zolbetuximab was approved in Japan for the treatment of patients with HER2^-, CLDN18.2⁺ unresectable, advanced/recurrent gastric cancer (the gastric cancer indication includes GEJ cancer). Zolbetuximab is also undergoing regulatory review for HER2^-, CLDN18.2⁺ advanced gastric or GEJ adenocarcinoma in the USA, the EU, China, Australia and several other countries. This article summarizes the milestones in the development of zolbetuximab leading to this first approval for the treatment of patients with CLDN18.2⁺ gastrointestinal malignancies.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.