Syed Yahiya Y
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2025 Apr 30. doi: 10.1007/s40265-025-02187-9.
Catumaxomab (Korjuny) is a first-in-class bispecific trifunctional rat-mouse hybrid monoclonal antibody currently under development with Lindis Biotech for malignant ascites, and bladder, gastric and ovarian cancers. It binds epithelial cell adhesion molecule (EpCAM) on tumour cells and CD3 on T cells, while its Fc domain engages Fcγ receptor-positive accessory cells, bringing immune and tumour cells into close proximity to enhance tumour cell killing through multiple immunological mechanisms. Initially approved in the EU on 20 April 2009 for malignant ascites in adults with EpCAM+ carcinomas when standard therapy was unavailable or no longer feasible, catumaxomab was marketed by Fresenius Biotech GmbH (later Neovii Biotech GmbH) before being withdrawn on 2 June 2017 for commercial reasons. Lindis Biotech later acquired the rights and pursued reapproval. On 11 February 2025, catumaxomab was approved in the EU for the intraperitoneal treatment of malignant ascites in adults with EpCAM+ carcinomas who are not eligible for further systemic anticancer therapy. This article summarizes the milestones in the development of catumaxomab leading to this new approval.
卡妥索单抗（科军尼）是首个双特异性三功能大鼠-小鼠杂交单克隆抗体，目前正与林迪斯生物技术公司合作开发，用于治疗恶性腹水以及膀胱癌、胃癌和卵巢癌。它可结合肿瘤细胞上的上皮细胞黏附分子（EpCAM）和T细胞上的CD3，而其Fc结构域可与Fcγ受体阳性辅助细胞结合，使免疫细胞和肿瘤细胞紧密靠近，通过多种免疫机制增强对肿瘤细胞的杀伤作用。卡妥索单抗最初于2009年4月20日在欧盟获批，用于治疗标准治疗不可用或不再可行的EpCAM+癌成年患者的恶性腹水，由费森尤斯生物技术有限公司（后为诺维生物技术有限公司）销售，后于2017年6月2日因商业原因退市。林迪斯生物技术公司后来获得了相关权利并寻求重新获批。2025年2月11日，卡妥索单抗在欧盟获批，用于腹腔内治疗不符合进一步全身抗癌治疗条件的EpCAM+癌成年患者的恶性腹水。本文总结了卡妥索单抗发展历程中促成此次新获批的重要节点。
