title: Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer.
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.
authors.affiliation: Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, 10 Center Drive, 8B09 MSC 1750, Bethesda, MD 20892, USA.
authors.forename: Ravi A
authors.initials: RA
authors.lastname: Madan
authors.forename: James L
authors.initials: JL
authors.lastname: Gulley
mesh_terms: D019496:Cancer Vaccines / Q000276:immunology*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D014020:Tissue Extracts / Q000276:immunology*; D014481:United States
chemical_list: D019496:Cancer Vaccines; D014020:Tissue Extracts; C511774:sipuleucel-T