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Title | Poteligeo (mogamulizumab-kpkc) FDA Drug Label |
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761051 |
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Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Mogamulizumab | Poteligeo | KW-0761|Mogamulizumab-kpkc | Poteligeo (mogamulizumab-kpkc) is a monoclonal antibody that binds to and inhibits C-C chemokine receptor 4 (CCR4) signaling, which leads to inhibition of Tregs and enhancement of host antitumor immunity (PMID: 25496334). Poteligeo (mogamulizumab-kpkc) is FDA approved for adult patients with relapsed or refractory mycosis fungoides or Sezary syndrome (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Unknown unknown | Sezary's disease | not applicable | Mogamulizumab | FDA approved | Actionable | In a Phase III trial (MAVORIC) that supported FDA approval, Poteligeo (mogamulizumab-kpkc) treatment resulted in significantly improved progression-free survival (7.7 vs 3.1 months, HR=0.53, p<0.0001) and objective response rate (28.0% vs 4.8%) compared to Zolinza (vorinostat) in patients with mycosis fungoides or Sézary syndrome (Blood 2017 130(Suppl 1):817). | detail... detail... |
Unknown unknown | mycosis fungoides | not applicable | Mogamulizumab | FDA approved | Actionable | In a Phase III trial (MAVORIC) that supported FDA approval, Poteligeo (mogamulizumab-kpkc) treatment resulted in significantly improved progression-free survival (7.7 vs 3.1 months, HR=0.53, p<0.0001) and objective response rate (28.0% vs 4.8%) compared to Zolinza (vorinostat) in patients with mycosis fungoides or Sézary syndrome (Blood 2017 130(Suppl 1):817). | detail... detail... |