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Catumaxomab is a first-in-class trifunctional bispecific monoclonal antibody that targets both epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 on T cells. It also possesses an Fc region capable of binding to Fc-gamma receptors on accessory immune cells such as macrophages and natural killer cells. This unique structure enables catumaxomab to form a bridge between tumor cells, T lymphocytes, and accessory immune effector cells, resulting in potent anti-tumor activity through direct cytotoxicity and immunostimulation. Catumaxomab was originally developed for the treatment of malignant ascites secondary to EpCAM-positive cancers (notably ovarian, gastric, pancreatic cancers), particularly in patients not eligible for further systemic anti-cancer therapy. The drug was first approved by the European Medicines Agency (EMA) in 2009 as the world’s first marketed bispecific T-cell engager antibody but was withdrawn from the market in 2017 due to commercial reasons despite demonstrated clinical efficacy. Development has since been re-initiated with new approvals granted for intraperitoneal treatment of malignant ascites in Europe as of February 2025[2][4][5][6][7][8][9].
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