FINDINGS

Experimental Vaccine for Prostate Cancer Endorsed

FDA Advisers Back Prostate Cancer Drug

Federal health advisers have endorsed an experimental vaccine for treating advanced prostate cancer as safe and apparently effective.

The Food and Drug Administration advisers voted unanimously yesterday that Provenge is safe. They then voted 13 to 4 that there is substantial evidence that it works against advanced prostate cancer that no longer responds to hormone treatment.

The FDA is not required to follow the advice of its advisory committees, but it usually does. A final FDA decision on whether to approve Provenge, also called sipuleucel-T, is expected May 15. The vaccine is made by Seattle-based Dendreon Corp.

Neither of two studies Dendreon submitted to the FDA in support of its application achieved their primary goal of showing Provenge delayed the progress of the disease, according to the agency.

But the results of the first study suggested that the vaccine could extend the lives of patients by 4 1/2 months compared with the lives of those given only dummy treatment. The only other prostate cancer drug shown to prolong the lives of patients is Taxotere, also called docetaxel.

If ultimately approved, Provenge would become the first of a new class of therapies designed to stimulate a patient's own immune system against cancer.

Parkinson's Drug Pulled Off the Market

A drug used by thousands of Parkinson's disease patients is being pulled from the market because of reports of heart valve damage.

The Food and Drug Administration said that pergolide, sold under the name Permax and also in generic versions, is being withdrawn at the agency's request.

There are other drugs in the same class that can be substituted, said Robert Temple of the FDA's office of drug evaluation. At least 14 patients have needed to have heart valves replaced.

He estimated that between 12,000 and 25,000 people currently use the drug, which is a dopamine agonist.

Pergolide came on the market in 1988, and label warnings were added in 2002 after reports of heart valve problems were received. In 2006, a boxed warning was added to the labeling for pergolide.