Mar 29, 2007 12:52 pm US/Eastern
Panel Begins Review Of Prostate Cancer Vaccine
FDA's Decision Likely In May
MIAMI (AP) ―
An expert panel convenes Thursday to consider a vaccine for men who have advanced prostate cancer. The panel is evaluating the vaccine for the Food and Drug Administration.
The product is called Provenge, made by a company called Dendreon. It's called a vaccine because it stimulates the immune system. But unlike other vaccines that prevent disease, this one is given to help stop disease in someone who is already sick.
Scientists explain that with this "personalized medicine", white blood cells are taken out and they're given an agent that activates them to attack the patient's prostate cancer cells.
So far, in two studies, there were essentially no side effects. The drug didn't do any better than a placebo in slowing the progression of the cancer, but there did seem to be a difference in survival. Those who got the drug lived an additional four months, on average. But because of problems with the way the studies were designed, FDA analysts suspect that improvement in people who got the drug might not hold up in further research.
Some in the medical community are concerned that a "no" vote by the committee could discourage the development of similar drugs.
Cost will also be an issue, especially for men without full insurance. Several other new cancer drugs that provide a few weeks or months of extra life cost several thousand dollars a month.
Dendreon officials aren't saying how much they might charge for Provenge if it is ultimately approved. The FDA's final decision is due by May 15.
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