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Ipilimumab

First Global Approval

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Abstract

Ipilimumab (Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma. In the EU, it is awaiting approval as second-line therapy for melanoma. Ipilimumab blocks the effects of the negative T-cell regulator CTLA-4, which may in turn augment T-cell responses to tumour cells. Preclinical studies have indicated that antibody blocking of CTLA-4 can lead to potent immune responses. Ipilimumab is also in development as first- and second-line therapy for prostate cancer where it has progressed to phase III clinical trials worldwide, and it is in phase II development for non-small cell lung cancer. Ipilimumab was originated by the University of California, Berkeley, in the US and subsequently licensed to Medarex, which was later acquired by Bristol-Myers Squibb. This article summarizes the milestones in the development of intravenous ipilimumab leading to this first approval.

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Authors and Affiliations

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

    Fiona Cameron & Glenn Whiteside

  2. Adis, a Wolters Kluwer Business, Auckland, New Zealand

    Caroline Perry

Authors
  1. Fiona Cameron
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  2. Glenn Whiteside
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  3. Caroline Perry
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Correspondence to Glenn Whiteside.

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Cameron, F., Whiteside, G. & Perry, C. Ipilimumab. Drugs 71, 1093–1104 (2011). https://doi.org/10.2165/11594010-000000000-00000

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