Overview
Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers typically affect the skin, causing various types of skin lesions. On August 8 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab injection (also known as Poteligeo) for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. It was approved for the same indications in Canada in June 2022. Mogamulizumab is derived from Kyowa Hakko Kirin's POTELLIGENT (®) technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Approval in Japan was granted on April 30 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.
Background
Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers typically affect the skin, causing various types of skin lesions. On August 8 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab injection (also known as Poteligeo) for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. It was approved for the same indications in Canada in June 2022. Mogamulizumab is derived from Kyowa Hakko Kirin's POTELLIGENT (®) technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Approval in Japan was granted on April 30 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.
Indication
Mogamulizumab is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
Associated Conditions
- Refractory Mycosis Fungoides and Sezary Syndrome
- Relapsed Mycosis Fungoides/Sezary Syndrome
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/20 | Phase 2 | Recruiting | |||
2024/02/29 | Phase 4 | Recruiting | Kyowa Kirin China Pharmaceutical Co., Ltd. | ||
2024/01/31 | Early Phase 1 | Recruiting | |||
2023/08/18 | Phase 2 | Recruiting | |||
2023/07/21 | Phase 2 | Recruiting | |||
2022/07/13 | N/A | Recruiting | |||
2022/06/10 | Phase 1 | Recruiting | |||
2021/06/18 | Phase 2 | Recruiting | City of Hope Medical Center | ||
2021/04/19 | Phase 1 | Recruiting | |||
2021/02/09 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kyowa Kirin, Inc. | 42747-761 | INTRAVENOUS | 4 mg in 1 mL | 3/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/22/2018 |
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 |
|---|---|---|---|---|---|
| Mogamulizumab Injection | 国药准字SJ20220018 | 生物制品 | 注射剂 | 10/11/2022 |
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 |
|---|---|---|---|---|---|
| POTELIGEO mogamulizumab 4 mg/mL concentrate for solution for infusion vial | 330232 | Medicine | A | 2/5/2021 |