{"title":"Retlirafusp Alfa: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-026-02305-1","DOIUrl":null,"url":null,"abstract":"<p><p>Retlirafusp alfa (<sup>®</sup>), a bifunctional antibody fusion protein combining a PD-L1-targeting antibody with a truncated form of the TGF-β receptor II (TGF-βRII) extracellular domain, is being developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd for the treatment of solid malignant tumours. In January 2026, retlirafusp alfa was approved for use in combination with fluorouracil and platinum-based drugs as a first-line treatment for locally advanced, unresectable, recurrent, or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJA) with a PD-L1 positive CPS ≥ 1, as assessed by a well-validated assay in China. This article summarizes the milestones in the development of retlirafusp alfa leading to this first approval for the treatment of advanced PD-L1 positive GC/GEJA.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"769-775"},"PeriodicalIF":14.7000,"publicationDate":"2026-05-01","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/s40265-026-02305-1","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/3/21 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Retlirafusp alfa (®), a bifunctional antibody fusion protein combining a PD-L1-targeting antibody with a truncated form of the TGF-β receptor II (TGF-βRII) extracellular domain, is being developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd for the treatment of solid malignant tumours. In January 2026, retlirafusp alfa was approved for use in combination with fluorouracil and platinum-based drugs as a first-line treatment for locally advanced, unresectable, recurrent, or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJA) with a PD-L1 positive CPS ≥ 1, as assessed by a well-validated assay in China. This article summarizes the milestones in the development of retlirafusp alfa leading to this first approval for the treatment of advanced PD-L1 positive GC/GEJA.
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.
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