PROVENGE (Sipuleucel-T) in Prostate Cancer: The First FDA-Approved Therapeutic Cancer Vaccine

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...

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Bibliographic Details
Published in:Clinical cancer research 2011-06, Vol.17 (11), p.3520-3526
Main Authors: CHEEVER, Martin A, HIGANO, Celestia S
Format: Article
Language:English
Subjects:
Acid Phosphatase - immunology
Antineoplastic agents
Biological and medical sciences
Cancer Vaccines - therapeutic use
Clinical Trials as Topic
Drug Approval
Granulocyte-Macrophage Colony-Stimulating Factor - immunology
Gynecology. Andrology. Obstetrics
Humans
Immunization
Leukocytes, Mononuclear - immunology
Male
Male genital diseases
Medical sciences
Nephrology. Urinary tract diseases
Pharmacology. Drug treatments
Prostatic Neoplasms - drug therapy
Prostatic Neoplasms - immunology
Protein Tyrosine Phosphatases - immunology
Recombinant Fusion Proteins - immunology
Tissue Extracts - therapeutic use
Tumors
Tumors of the urinary system
United States
United States Food and Drug Administration
Urinary tract. Prostate gland
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Summary: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.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.ccr-10-3126