| Monoclonal antibody | |
|---|---|
| Type | Trifunctional antibody |
| Source | Rat/mouse hybrid |
| Target | EpCAM,CD3 |
| Clinical data | |
| Trade names | Removab, others |
| AHFS/Drugs.com | International Drug Names |
| Routes of administration | intraperitoneal infusion |
| ATC code | |
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| Legal status | |
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 N Y (what is this?) (verify) | |
Catumaxomab, sold under the brand nameRemovab among others, is arat-mouse hybridmonoclonal antibody which is used to treatmalignantascites, a condition occurring in people withmetastasizing cancer. It binds to antigensCD3 andEpCAM. It was developed byFresenius Biotech andTrion Pharma (Germany).[3]
In the European Union, catumaxomab isindicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.[1][2][4][5] Ascites is an accumulation of fluid in theperitoneal cavity.[6][7][8]
Common adverse effects include fever,nausea and vomiting. Fever and pain should be controlled by givingNSAIDs,analgetics orantipyretics before application of catumaxomab.[9] All side effects were fully reversible in studies. Most are caused by the liberation ofcytokines.[4]
Many types of cancer cells carry EpCAM (epithelial cell adhesion molecule) on their surface. By binding to such a cell via one arm, to aT lymphocyte via the other arm and to anantigen-presenting cell like amacrophage, anatural killer cell or adendritic cell via the heavy chains, an immunological reaction against the cancer cell is triggered. Removing cancer cells from the abdominal cavity reduces the tumour burden which is seen as the cause for ascites in people with cancer.[4][10][11]
Catumaxomab consists of one "half" (oneheavy chain and onelight chain) of an anti-EpCAM antibody and one half of an anti-CD3 antibody, so that each molecule of catumaxomab can bind both EpCAM and CD3. In addition, the Fc-region can bind to anFc receptor on accessory cells like other antibodies, which has led to calling the drug atrifunctional antibody.
Catumaxomab was developed by Trion Pharma, based on preliminary work by theHelmholtz Zentrum München. Dr. Horst Lindhofer is listed at the primary inventor of the patent.[12] Fresenius Biotech conductedclinical trials and filed the drug for approval with theEuropean Medicines Agency (EMA). It was approved in Europe on 20 April 2009.[13] In 2013, catumaxomab was voluntarily withdrawn from the US market and in 2017 in the EU market for commercial reasons.[14] The product has not been marketed in the EU since 2014.[15]
In October 2024, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Korjuny, intended for the intraperitoneal treatment of malignant ascites.[1] The applicant for this medicinal product is Lindis Biotech GmbH.[1][16] Catumaxomab was approved for medical use in the European Union in February 2025.[1][2]
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