Zanidatamab: First Approval.

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-05-01 Epub Date: 2025-03-20 DOI:10.1007/s40265-025-02163-3

Susan J Keam

引用次数: 0

Abstract

Zanidatamab (ZIIHERA^®; zanidatamab- hrii), a bi-specific antibody targeting two non-overlapping epitopes of the human epidermal growth factor receptor 2 (HER2) protein, is being developed by Jazz Pharmaceuticals and BeiGene Ltd under license agreements from Zymeworks Inc., the developer of the molecule, for the treatment of HER2-expressing solid tumours. This article summarizes the milestones in the development of zanidatamab leading to this first accelerated approval for use in adults with previously treated, unresectable or metastatic HER2+ (IHC3+) biliary tract cancer (BTC), as detected by an FDA-approved test.

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Zanidatamab：首次批准。

Zanidatamab (ZIIHERA®;zanidatamab- hrii是一种双特异性抗体，靶向人类表皮生长因子受体2 （HER2）蛋白的两个非重叠表位，由Jazz制药公司和百济神有限公司根据该分子的开发商Zymeworks公司的许可协议开发，用于治疗表达HER2的实体肿瘤。本文总结了zanidatamab的发展里程碑，这是fda批准的一项检测检测到的首次加速批准用于先前治疗过的、不可切除的或转移性HER2+ (IHC3+)胆道癌（BTC）的成人患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.