FDA Approves Provenge Prostate Cancer Immunotherapy

Filed in archive Drugs, Vaccines and Therapeutics on April 29, 2010

The FDA has approved Dendreon's Provenge (sipuleucel-T) , a novel cancer vaccine that promises to extend the lives of patients with advanced prostate cancer by several months. The therapy is indicated specifically for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Provenge is an autologous cellular immunotherapy, and each dose is manufactured by obtaining a patient's immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient's own cells are returned to the patient to treat the prostate cancer.

© Provenge

In the clinical trial leading to this FDA approval, 12 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months.

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