Catumaxomab

Overview

Catumaxumab is a trifunctional monoclonal antibody developed for use in cancer treatment. It has affinity for T-cells, accessory immune cells, and cancer cells. Catumaxumab was initially authorized for market by the European Medicines Agency in April 2009 for the treatment of malignant ascites . Its market authorization was withdrawn in the EU in June 2017 at the manufacturer's request due to the company's insolvency. Catumaxumab was approved for market in Canada in May 2012 for the same condition . It is currently available under the brand name Removab.

Indication

For use in the management of malignant ascites tumours via intraperitoneal infusion where standard therapy is not available or feasible .

Associated Conditions

Ascites, Malignant

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC	2021/03/29	NCT04819399	Phase 1	UNKNOWN	Lindis Biotech GmbH
Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine	2021/03/16	NCT04799847	Phase 1	Recruiting	LintonPharm Co.,Ltd.
Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis	2020/01/09	NCT04222114	Phase 3	Recruiting	LintonPharm Co.,Ltd.
Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer	2013/03/21	NCT01815528	Phase 2	Completed	JSehouli
Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab	2013/02/06	NCT01784900	Phase 2	Terminated	Gustave Roussy, Cancer Campus, Grand Paris
A Open Label, Dose Escalating Study to Evaluate the Safety and Tolerability of Ascending Intravenous (i.v.) Doses of Catumaxomab in Epithelial Cancer Patients	2011/03/22	NCT01320020	Phase 1	Terminated	Neovii Biotech
Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission	2010/11/23	NCT01246440	Phase 2	Completed	Grupo Español de Investigación en Cáncer de Ovario
Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites	2010/02/09	NCT01065246	Phase 2	Completed	Neovii Biotech
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers	2009/01/14	NCT00822809	Phase 3	Completed	Neovii Biotech
Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer	2007/11/26	NCT00563836	Phase 2	Completed	Neovii Biotech

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
REMOVAB	fresenius biotech gmbh	02385732	Solution - Intraperitoneal	0.1 MG / ML	N/A
REMOVAB	fresenius biotech gmbh	02385724	Solution - Intraperitoneal	0.1 MG / ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
REMOVAB 10 microgramos CONCENTRADO PARA SOLUCION PARA PERFUSION	Fresenius Biotech Gmbh	09512001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
REMOVAB 50 microgramos CONCENTRADO PARA SOLUCION PARA PERFUSION	Fresenius Biotech Gmbh	09512002	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies

5 months ago

• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease. • Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials. • Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.

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