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Prostate Cancer Vaccine May Get FDA Approval
Date:4/27/2010

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

TUESDAY, April 27 (HealthDay News) -- The anticipated approval this week of a therapeutic prostate cancer vaccine by the U.S. Food and Drug Administration could be a milestone against the disease and cancer in general, experts say.

The vaccine, called 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 and appears on the threshold of approval," said Dr. J. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society.

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 cautioned. "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 of that same disease," he said.

But that benefit would have to be shown in clinical trials, Lichtenfeld said.

"If it does get approved it will be groundbreaking." Lichtenfeld said. "It will represent a new treatment option. It will have a modest impact on prostate cancer survival, but it's small changes in treatments over time that add up to a major improvement. So I wouldn't be discouraged by what is a small increment in survival."

Provenge is a therapeutic (not preventative) vaccine that is made from the patient's own white blood cells. Once re
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