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Mogamulizumab: first global approval.

Abstract

Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity. This is achieved largely by reducing fucose content in the oligosaccharide structure of the Fc region. Mogamulizumab has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukaemia-lymphoma (ATL) and is the first Potelligent® antibody to receive marketing approval anywhere in the world. Phase II development is underway for adult T-cell leukaemia-lymphoma (ATL) and cutaneous T-cell lymphoma in the US, and for peripheral T-cell lymphoma in the US and Europe. Amgen is conducting a phase I US-based study in patients with asthma. This article summarizes the milestones in the development of intravenous mogamulizumab leading to this first approval.

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  • Authors+Show Affiliations

    ,

    Adis RD Insight, Auckland, New Zealand.

    , ,

    Source

    Drugs 72:9 2012 Jun 18 pg 1293-8

    MeSH

    Antibodies, Monoclonal, Humanized
    Clinical Trials as Topic
    Drug Approval
    Humans
    Receptors, CCR4

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    22686619

    Citation

    Subramaniam, Joshuan M., et al. "Mogamulizumab: First Global Approval." Drugs, vol. 72, no. 9, 2012, pp. 1293-8.
    Subramaniam JM, Whiteside G, McKeage K, et al. Mogamulizumab: first global approval. Drugs. 2012;72(9):1293-8.
    Subramaniam, J. M., Whiteside, G., McKeage, K., & Croxtall, J. C. (2012). Mogamulizumab: first global approval. Drugs, 72(9), pp. 1293-8. doi:10.2165/11631090-000000000-00000.
    Subramaniam JM, et al. Mogamulizumab: First Global Approval. Drugs. 2012 Jun 18;72(9):1293-8. PubMed PMID: 22686619.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Mogamulizumab: first global approval. AU - Subramaniam,Joshuan M, AU - Whiteside,Glenn, AU - McKeage,Kate, AU - Croxtall,Jamie C, PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2012/10/10/medline SP - 1293 EP - 8 JF - Drugs JO - Drugs VL - 72 IS - 9 N2 - Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity. This is achieved largely by reducing fucose content in the oligosaccharide structure of the Fc region. Mogamulizumab has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukaemia-lymphoma (ATL) and is the first Potelligent® antibody to receive marketing approval anywhere in the world. Phase II development is underway for adult T-cell leukaemia-lymphoma (ATL) and cutaneous T-cell lymphoma in the US, and for peripheral T-cell lymphoma in the US and Europe. Amgen is conducting a phase I US-based study in patients with asthma. This article summarizes the milestones in the development of intravenous mogamulizumab leading to this first approval. SN - 1179-1950 UR - https://www.unboundmedicine.com/medline/citation/22686619/Mogamulizumab:_first_global_approval_ L2 - https://dx.doi.org/10.2165/11631090-000000000-00000 DB - PRIME DP - Unbound Medicine ER -