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 Its market authorization was withdrawn in the EU in June 2017 at the manufacturer's request due to the company's insolvency.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.
Background
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 Its market authorization was withdrawn in the EU in June 2017 at the manufacturer's request due to the company's insolvency.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 |
---|---|---|---|---|---|
2021/03/29 | Phase 1 | UNKNOWN | |||
2021/03/16 | Phase 1 | Recruiting | LintonPharm Co.,Ltd. | ||
2020/01/09 | Phase 3 | Recruiting | LintonPharm Co.,Ltd. | ||
2013/03/21 | Phase 2 | Completed | JSehouli | ||
2013/02/06 | Phase 2 | Terminated | |||
2011/03/22 | Phase 1 | Terminated | Neovii Biotech | ||
2010/11/23 | Phase 2 | Completed | Grupo Español de Investigación en Cáncer de Ovario | ||
2010/02/09 | Phase 2 | Completed | Neovii Biotech | ||
2009/01/14 | Phase 3 | Completed | Neovii Biotech | ||
2007/11/26 | Phase 2 | Completed | Neovii Biotech |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |