, Volume 71, Issue 8, pp 1093–1104


First Global Approval
R&D Insight Profile

DOI: 10.2165/11594010-000000000-00000

Cite this article as:
Cameron, F., Whiteside, G. & Perry, C. Drugs (2011) 71: 1093. doi:10.2165/11594010-000000000-00000


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.

Copyright information

© Adis Data Information BV 2011

Authors and Affiliations

  • Fiona Cameron
    • 1
  • Glenn Whiteside
    • 1
  • Caroline Perry
    • 2
  1. 1.R&D Insight, Wolters Kluwer Pharma SolutionsMairangi Bay, North Shore, AucklandNew Zealand
  2. 2.Adis, a Wolters Kluwer BusinessAucklandNew Zealand