Trastuzumab Rezetecan: First Approval

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and Conflict of interest</b> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </b>Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr">Abstract</p><p dir="ltr">Trastuzumab rezetecan (Avida 艾维达^®) is a human epidermal growth factor receptor 2 (HER2)-directed antibody–drug conjugate being developed by Jiangsu HengRui Medicine Co., Ltd. for the treatment of various solid tumours, including breast cancer, colorectal cancer, gastric cancer, gastroesophageal junction adenocarcinoma and lung cancer. In May 2025, it was approved by the National Medical Products Administration of China for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have <i>human epidermal growth factor receptor 2</i> (<i>HER2</i>) [<i>ERBB2</i>]-activating mutations and have received ≥ 1 previous systemic treatment. This article summarizes the milestones in the development of trastuzumab rezetecan leading to this first approval.</p><p dir="ltr">© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2025</p>