PROVENGE (Sipuleucel-T) in prostate cancer: the first FDA-approved therapeutic cancer vaccine

Clin Cancer Res. 2011 Jun 1;17(11):3520-6. doi: 10.1158/1078-0432.CCR-10-3126. Epub 2011 Apr 6.


Sipuleucel-T (PROVENGE; Dendreon) is the first therapeutic cancer vaccine to be approved by the U.S. Food and Drug Administration. In men who have metastatic castration-resistant prostate cancer with no or minimal symptoms, sipuleucel-T prolongs median survival by 4.1 months compared with results in those treated with placebo. At 3 years, the proportion of patients in the vaccine group who were alive was 50% higher than that in the control group (31.7% versus 21.7%, respectively). Sipuleucel-T, which is designed to elicit an immune response to prostatic acid phosphatase, uses the patient's own immune system to recognize and combat his cancer. Currently, no other agents are available that offer a survival benefit for this population of asymptomatic patients who have not been treated with chemotherapy, except for docetaxel (whose inherent toxicities often lead patients and physicians to delay administration until symptoms develop). Straightforward strategies to increase the efficacy of sipuleucel-T are likely to provide even greater benefit. The preclinical and clinical development of sipuleucel-T is reviewed, and approaches to enhance efficacy are considered herein.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Acid Phosphatase / immunology
  • Cancer Vaccines / therapeutic use*
  • Clinical Trials as Topic
  • Drug Approval
  • Granulocyte-Macrophage Colony-Stimulating Factor / immunology
  • Humans
  • Immunization
  • Leukocytes, Mononuclear / immunology
  • Male
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / immunology
  • Protein Tyrosine Phosphatases / immunology*
  • Recombinant Fusion Proteins / immunology
  • Tissue Extracts / therapeutic use*
  • United States
  • United States Food and Drug Administration


  • Cancer Vaccines
  • Recombinant Fusion Proteins
  • Tissue Extracts
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • sipuleucel-T
  • Acid Phosphatase
  • PA2024 fusion protein, human
  • prostatic acid phosphatase
  • Protein Tyrosine Phosphatases