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

Author(s): Madan RA, Gulley JL

Affiliation(s): Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, 10 Center Drive, 8B09 MSC 1750, Bethesda, MD 20892, USA.

Publication date & source: 2011-02, Expert Rev Vaccines., 10(2):141-50.

Publication type: Review

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.