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Prostate Cancer Vaccine Gains FDA Approval
Date:4/29/2010

Breakthrough approach lengthens survival, to varying degrees, for men with advanced disease, studies found,,

THURSDAY, April 29 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday granted approval to Provenge, a therapeutic vaccine aimed at preventing the spread of prostate cancer in men with an advanced form of the disease.

The new approval is limited to "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," the FDA said.

"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.

Experts say the drug's approval could be a milestone against the disease and cancer in general.

Provenge appears to extend survival in men with advanced prostate cancer, and it does so without the serious side effects associated with chemotherapy, radiation and hormone therapy.

"It is certainly exciting to see a drug that has made it this far," Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society, said earlier this week.

The vaccine is not aimed at preventing prostate cancer in men who have not developed the disease, and it is far from a cure for those who have it, Lichtenfeld stressed. "Provenge represents a modest advance in survival for patients with advanced prostate cancer, but the drug doesn't delay the progression of the disease," he said.

Still, it might prove possible to use Provenge in the earlier stages of prostate cancer, where it might be even more effective, Lichtenfeld said. "The hope is if a vaccine is effective in late-stage disease that it is going to be even more effective in the earlier treatment
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