Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer

Expert Rev Vaccines. 2011 Feb;10(2):141-50. doi: 10.1586/erv.10.173.


Sipuleucel-T (Provenge) is the first therapeutic cancer vaccine approved by the US FDA. The approval heralds the long-awaited promise of improved patient survival with minimal toxicity by therapies designed to generate an active, specific anticancer immune response. The development of this first-in-class agent as well as other therapeutic vaccines in clinical evaluation has also led to a better understanding of relevant patient populations and end points for clinical trials. This article discusses the development and approval of sipuleucel-T in the context of other approved therapies for prostate cancer, as well as controversies and novel paradigms brought about by this new agent.

Publication types

  • Review

MeSH terms

  • Cancer Vaccines / immunology*
  • Clinical Trials as Topic
  • Drug Approval
  • Humans
  • Male
  • Prostatic Neoplasms / therapy*
  • Tissue Extracts / immunology*
  • United States


  • Cancer Vaccines
  • Tissue Extracts
  • sipuleucel-T