Catumaxomab (Removab)

in US clinical trials; was approved in Europe but approval withdrawn in 2017.

General information

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

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

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• 2017-06-02: Approval withdrawn at request of the manufacturer, for commercial reasons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

• Catumaxomab (Removab) patient drug information (Fresenius Biotech)

Also known as

• Brand name: Removab