in US clinical trials; was approved in Europe but approval withdrawn in 2017.
Class/mechanism: Hybrid rat-mouse monoclonal antibody that has one arm directed against epithelial cell adhesion molecule (EpCAM) and another arm against CD3. This brings into close proximity tumor cells, which tend to overexpress EpCAM, and mature T-cells, which express CD3. Additionally, accessory immune cells such as macrophages, NK cells, and dentritic cells interact with the Fc domain of catumaxomab. The close proximity of these cells is postulated to enhance immune cell activation and destruction of tumor cells.
Route: IP (intraperitoneal)
Extravasation: no information
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History of changes in EMA indication
- 2009-04-20: Initial authorization for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
- 2017-06-02: Approval withdrawn at request of the manufacturer, for commercial reasons
Patient drug information
Also known as
- Brand name: Removab