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

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

Ravi A Madan  1 , James L Gulley
Affiliations
Review

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

Ravi A Madan et al. Expert Rev Vaccines. 2011 Feb.

Abstract

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.

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Figures

Figure 1
Figure 1
Sipuleucel-T improves survival but not progression in metastatic castration-resistant prostate cancer. A: primary efficacy analysis of sipuleucel-T from the IMPACT study (HR 0.78; P = 0.03). B: overall survival analysis with and without censoring at initiation of docetaxel therapy. A consistent treatment effect was observed after censoring at time of docetaxel treatment (HR 0.65; P = 0.009)
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