Zolbetuximab (VYLOY™) 是一种重组嵌合抗密蛋白 18.2 (CLDN18.2) 单克隆抗体 (mAb)，由 Astellas Pharma Inc. 开发，用于治疗 HER2 阴性 (HER2-)、CLDN18 患者。 2 阳性 (CLDN18.2 ) 晚期胃或胃食管交界处 (GEJ) 腺癌和 CLDN18.2 晚期胰腺腺癌。 2024年3月，zolbetuximab在日本获批用于治疗HER2-、CLDN18.2不可切除的晚期/复发性胃癌（胃癌适应症包括GEJ癌）患者。 Zolbetuximab 还在美国、欧盟、中国、澳大利亚和其他几个国家接受针对 HER2-、CLDN18.2 晚期胃或 GEJ 腺癌的监管审查。本文总结了 zolbetuximab 开发过程中的里程碑，该药物首次获批用于治疗 CLDN18.2 胃肠道恶性肿瘤患者。© 2024。作者获得 Springer Nature Switzerland AG 的独家许可。

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.© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.