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Mogamulizumab

First Global Approval

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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 and Affiliations

  1. Adis R&D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Joshuan M. Subramaniam & Glenn Whiteside

  2. Adis, Auckland, New Zealand

    Kate McKeage & Jamie C. Croxtall

Authors
  1. Joshuan M. Subramaniam
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  2. Glenn Whiteside
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  3. Kate McKeage
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  4. Jamie C. Croxtall
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Corresponding author

Correspondence to Glenn Whiteside.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Subramaniam, J.M., Whiteside, G., McKeage, K. et al. Mogamulizumab. Drugs 72, 1293–1298 (2012). https://doi.org/10.2165/11631090-000000000-00000

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  • DOI: https://doi.org/10.2165/11631090-000000000-00000

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