Difference between revisions of "Mogamulizumab (Poteligeo)"
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==Mechanism of action== | ==Mechanism of action== | ||
| − | From the [ | + | From the [https://www.cancer.gov/drugdictionary?CdrID=500479 NCI Drug Dictionary]: A humanized monoclonal antibody directed against C-C chemokine receptor 4 (CCR4) with potential anti-inflammatory and antineoplastic activities. Mogamulizumab selectively binds to and blocks the activity of CCR4, which may inhibit CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, and chemokine-mediated angiogenesis. In addition, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells. CCR4, a G-coupled-protein receptor for C-C chemokines such MIP-1, RANTES, TARC and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and some types of neurons. <ref name="insert">[https://www.poteligeohcp.com/Content/files/prescribing-information.pdf Mogamulizumab (Poteligeo) package insert]</ref><ref>[[:File:Mogamulizumab.pdf | Mogamulizumab (Poteligeo) package insert (locally hosted backup)]]</ref><ref>[https://www.poteligeohcp.com Poteligeo manufacturer's website]</ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 8: | Line 8: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2018-08-08: Initial approval for adult patients with relapsed or refractory [[Cutaneous T-cell lymphoma|mycosis fungoides (MF) or Sézary syndrome (SS)]] after at least one prior systemic therapy. ''(Based on MAVORIC)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2018-11-22: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2022-06-02: Initial notice of compliance for the treatment of adult patients with relapsed or refractory [[Cutaneous T-cell lymphoma|mycosis fungoides (MF) or Sézary syndrome (SS)]] after at least one prior systemic therapy. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2012-03-30: Initial approval for the treatment of recurrent or relapsed CCR4-positive [[adult T-cell leukemia-lymphoma|adult T-cell leukemia/lymphoma]]. | ||
| + | *2014-03-17: New additional indications for the treatment of relapsed or refractory CCR4-positive [[peripheral T-cell lymphoma]] and relapsed or refractory CCR4-positive [[cutaneous T-cell lymphoma]]. | ||
| + | *2014-12-18: Revised indication and a new dosage for the treatment of CCR4-positive [[adult T-cell leukemia-lymphoma|adult T-cell leukemia/lymphoma]]. | ||
| + | *2018-08-21: New indications and a new dosage for the treatment of relapsed or refractory [[cutaneous T-cell lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
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*'''Generic name:''' mogamulizumab-kpkc | *'''Generic name:''' mogamulizumab-kpkc | ||
*'''Brand name:''' Poteligeo | *'''Brand name:''' Poteligeo | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:Anti-CCR4 antibodies]] | [[Category:Anti-CCR4 antibodies]] | ||
[[Category:Anti-CD194 antibodies]] | [[Category:Anti-CD194 antibodies]] | ||
| Line 26: | Line 37: | ||
[[Category:Peripheral T-cell lymphoma medications]] | [[Category:Peripheral T-cell lymphoma medications]] | ||
| + | [[Category:EMA approved in 2018]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2022]] | ||
| + | [[Category:PMDA approved in 2012]] | ||
Latest revision as of 20:22, 27 June 2024
Mechanism of action
From the NCI Drug Dictionary: A humanized monoclonal antibody directed against C-C chemokine receptor 4 (CCR4) with potential anti-inflammatory and antineoplastic activities. Mogamulizumab selectively binds to and blocks the activity of CCR4, which may inhibit CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, and chemokine-mediated angiogenesis. In addition, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells. CCR4, a G-coupled-protein receptor for C-C chemokines such MIP-1, RANTES, TARC and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and some types of neurons. [1][2][3]
Diseases for which it is used
History of changes in FDA indication
- 2018-08-08: Initial approval for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. (Based on MAVORIC)
History of changes in EMA indication
- 2018-11-22: Initial authorization
History of changes in Health Canada indication
- 2022-06-02: Initial notice of compliance for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
History of changes in PMDA indication
- 2012-03-30: Initial approval for the treatment of recurrent or relapsed CCR4-positive adult T-cell leukemia/lymphoma.
- 2014-03-17: New additional indications for the treatment of relapsed or refractory CCR4-positive peripheral T-cell lymphoma and relapsed or refractory CCR4-positive cutaneous T-cell lymphoma.
- 2014-12-18: Revised indication and a new dosage for the treatment of CCR4-positive adult T-cell leukemia/lymphoma.
- 2018-08-21: New indications and a new dosage for the treatment of relapsed or refractory cutaneous T-cell lymphoma.
Also known as
- Code name: KW-0761
- Generic name: mogamulizumab-kpkc
- Brand name: Poteligeo