Difference between revisions of "Catumaxomab (Removab)"
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==General information== | ==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.<ref name="insert">[http://removab.com/tl_files/media/PDFs/110408_Removab_Produktmono_engl_V4.pdf Catumaxomab (Removab) package insert]</ref><ref>[ | + | 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.<ref name="insert">[http://removab.com/tl_files/media/PDFs/110408_Removab_Produktmono_engl_V4.pdf Catumaxomab (Removab) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/catumaxomab.pdf Catumaxomab (Removab) package insert (locally hosted backup)]</ref> |
<br>Route: IP (intraperitoneal) | <br>Route: IP (intraperitoneal) | ||
<br>Extravasation: no information | <br>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 | + | 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 or the prescribing information.<ref name="insert"></ref> |
==History of changes in EMA indication== | ==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== | ==Patient drug information== | ||
*[http://removab.com/?file=tl_files/media/PDFs/100921_PatBrsch-Removab-en_RZ.pdf Catumaxomab (Removab) patient drug information (Fresenius Biotech)]<ref>[http://removab.com/?file=tl_files/media/PDFs/100921_PatBrsch-Removab-en_RZ.pdf Catumaxomab (Removab) patient drug information (Fresenius Biotech)]]</ref> | *[http://removab.com/?file=tl_files/media/PDFs/100921_PatBrsch-Removab-en_RZ.pdf Catumaxomab (Removab) patient drug information (Fresenius Biotech)]<ref>[http://removab.com/?file=tl_files/media/PDFs/100921_PatBrsch-Removab-en_RZ.pdf Catumaxomab (Removab) patient drug information (Fresenius Biotech)]]</ref> | ||
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[[Category:Intracavitary medications]] | [[Category:Intracavitary medications]] | ||
| − | + | [[Category:Anti-EpCAM-CD3 bispecific antibodies]] | |
| − | [[Category:Anti-EpCAM | ||
| − | |||
[[Category:EMA approved in 2009]] | [[Category:EMA approved in 2009]] | ||
[[Category:EMA withdrawn in 2017]] | [[Category:EMA withdrawn in 2017]] | ||
[[Category:Discontinued drugs]] | [[Category:Discontinued drugs]] | ||
Latest revision as of 01:00, 29 June 2024
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.[1][2]
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 or the prescribing information.[1]
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
Also known as
- Brand name: Removab