Catumaxomab

In the European Union, catumaxomab is indicated 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.{{cite web | title = European Public Assessment Report for March 2009 | url = https://www.ema.europa.eu/en/documents/overview/removab-epar-summary-public_en.pdf | publisher = European Medicines Agency | date = March 2009 }}{{cite journal | vauthors = Heiss MM, Murawa P, Koralewski P, Kutarska E, Kolesnik OO, Ivanchenko VV, Dudnichenko AS, Aleknaviciene B, Razbadauskas A, Gore M, Ganea-Motan E, Ciuleanu T, Wimberger P, Schmittel A, Schmalfeldt B, Burges A, Bokemeyer C, Lindhofer H, Lahr A, Parsons SL | display-authors = 6 | title = The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial | journal = International Journal of Cancer | volume = 127 | issue = 9 | pages = 2209–21 | date = November 2010 | pmid = 20473913 | pmc = 2958458 | doi = 10.1002/ijc.25423 }} Ascites is an accumulation of fluid in the peritoneal cavity.{{cite journal | vauthors = Sebastian M | title = Review of catumaxomab in the treatment of malignant ascites | journal = Cancer Management and Research | volume = 2 | issue = | pages = 283–6 | date = November 2010 | pmid = 21188120 | pmc = 3004584 | doi = 10.2147/CMR.S14115 | doi-access = free }}{{cite journal | vauthors = Ammouri L, Prommer EE | title = Palliative treatment of malignant ascites: profile of catumaxomab | journal = Biologics: Targets and Therapy | volume = 4 | issue = | pages = 103–10 | date = May 2010 | pmid = 20531969 | pmc = 2880345 | doi = 10.2147/btt.s6697 | doi-access = free }}{{cite journal | vauthors = Lordick F, Ott K, Weitz J, Jäger D | title = The evolving role of catumaxomab in gastric cancer | journal = Expert Opinion on Biological Therapy | volume = 8 | issue = 9 | pages = 1407–15 | date = September 2008 | pmid = 18694358 | doi = 10.1517/14712598.8.9.1407 | s2cid = 73237824 }}

Common adverse effects include fever, nausea and vomiting. Fever and pain should be controlled by giving NSAIDs, analgetics or antipyretics before application of catumaxomab.{{cite book | vauthors = Schubert-Zsilavecz M, Wurglics M | title = Neue Arzneimittel | date = 2009 }} All side effects were fully reversible in studies. Most are caused by the liberation of cytokines.

File:Catumaxomab mechanism.svg

Many types of cancer cells carry EpCAM (epithelial cell adhesion molecule) on their surface. By binding to such a cell via one arm, to a T lymphocyte via the other arm and to an antigen-presenting cell like a macrophage, a natural killer cell or a dendritic 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.{{cite web | url = http://www.fresenius.se/internet/fag/com/faginpub.nsf/Content/P-Info2004_01_15 | archive-url = https://web.archive.org/web/20100826230959/http://www.fresenius.se/internet/fag/com/faginpub.nsf/Content/P-Info2004_01_15 | archive-date = 26 August 2010 | title = Capital Market Day Fresenius Biotech: Fresenius concentrates biotechnology activities on antibody and innovative cell therapies | work = Fresenius SE }}{{cite journal | vauthors = Ruf P, Gires O, Jäger M, Fellinger K, Atz J, Lindhofer H | title = Characterisation of the new EpCAM-specific antibody HO-3: implications for trifunctional antibody immunotherapy of cancer | journal = British Journal of Cancer | volume = 97 | issue = 3 | pages = 315–21 | date = August 2007 | pmid = 17622246 | pmc = 2360319 | doi = 10.1038/sj.bjc.6603881 }}

Catumaxomab consists of one "half" (one heavy chain and one light 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 an Fc receptor on accessory cells like other antibodies, which has led to calling the drug a trifunctional antibody.

File:Catumaxomab structure.svg

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Catumaxomab was developed by Trion Pharma, based on preliminary work by the Helmholtz Zentrum München. Dr. Horst Lindhofer is listed at the primary inventor of the patent.{{Cite patent | country = EP | number = 1315520 | title = Use of Trifunctional Bispecific and Trispecific Antibodies for the Treatment of Malignant Ascites | inventor = Lindhofer H | assign1 = Trion Pharma GmbH }} Fresenius Biotech conducted clinical trials and filed the drug for approval with the European Medicines Agency (EMA). It was approved in Europe on 20 April 2009.{{Cite web |url=http://www.lifescience-online.com/TRION_Pharma__Trifunctional_Antibody_Catumaxomab_K,16211.html?portalPage=Lifescience%20Today.News |title=TRION Pharma: Trifunctional Antibody Catumaxomab Kills Cancer Stem Cells |access-date=2009-11-19 |archive-url=https://web.archive.org/web/20110713204533/http://www.lifescience-online.com/TRION_Pharma__Trifunctional_Antibody_Catumaxomab_K,16211.html?portalPage=Lifescience%20Today.News |archive-date=2011-07-13 |url-status=dead }} In 2013, catumaxomab was voluntarily withdrawn from the US market and in 2017 in the EU market for commercial reasons.{{cite web | title = Neovii completes marketing authorisation withdrawal of Removab in the European Union | date = 26 July 2017 | url = https://neovii.com/neovii-completes-marketing-authorisation-withdrawal-of-removab-in-the-european-union/ | publisher = Neovii Biotech GmbH | access-date = 23 March 2018 | archive-date = 4 August 2021 | archive-url = https://web.archive.org/web/20210804133933/https://neovii.com/neovii-completes-marketing-authorisation-withdrawal-of-removab-in-the-european-union/ | url-status = dead }} The product has not been marketed in the EU since 2014.{{cite web | title = Removab: Withdrawal of the marketing authorisation in the European Union | url = http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/human/000972/WC500231226.pdf | work = European Medicines Agency | date = 10 July 2017 | access-date = 23 March 2018 | archive-date = 15 June 2018 | archive-url = https://web.archive.org/web/20180615015615/http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/human/000972/WC500231226.pdf | url-status = dead }}

In October 2024, the Committee for Medicinal Products for Human Use of the European 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. The applicant for this medicinal product is Lindis Biotech GmbH.{{cite web | title=Korjuny EPAR | website=European Medicines Agency (EMA) | date=17 October 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny | access-date=19 October 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite web | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024 | website=European Medicines Agency (EMA) | date=18 October 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2024 | access-date=21 October 2024}} Catumaxomab was approved for medical use in the European Union in February 2025.{{cite web | title=Korjuny PI | website=Union Register of medicinal products | date=12 February 2025 | url=https://ec.europa.eu/health/documents/community-register/html/h1826.htm | access-date=7 March 2025}}

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