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Mogamulizumab

Generic Name
Mogamulizumab
Brand Names
Poteligeo
Drug Type
Biotech
CAS Number
1159266-37-1
Unique Ingredient Identifier
YI437801BE

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
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