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A number medicines work via the immune system. Even androgen deprivation has been shown to have an activating effect on the immune system. Provenge®, approved by the FDA in 2010, works by enhancing the immune system’s ability to recognize and respond to prostate cancer. Ipilimumab, another new immune medicine that functions by inhibiting the regulatory cells of the immune system—the T-Regulatory cells—is being evaluated in phase III trials in prostate cancer. In addition, a variety of agents such as Leukine®, low-dose cytoxan, and Celebrex® have anticancer effects mediated by the immune system.

The FDA approval of sipuleucel-T (Provenge®) is for treatment of prostate cancer patients who are both metastatic, and castrate resistant. These patients, according to the FDA labeling, should also have very few cancer symptoms (minimally symptomatic), or no cancer symptoms (asymptomatic). In random clinical trials, sipuleucel-T prolonged survival among men with similar disease status. However, no significant effect on the time to objective disease progression was observed.

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