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Date Submitted: 12/11/07
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FDA Panel Backs Prostate Cancer Vaccine



Added by Bryan

Description: A U.S. Food and Drug Administration advisory panel voted Thursday to support approval of Provenge, a vaccine aimed at extending survival for patients with deadly metastatic prostate cancer.

The FDA panel voted unanimously that the vaccine was "reasonably safe," noting that while it failed to meet some study endpoints, it did extend patient survival, according to published reports.

The panel then voted 13-to-4 to say there was substantial evidence to show the vaccine was effective for treating advanced prostate cancer that no longer responds to standard hormone treatment.

The FDA does not have to follow the advice of its advisory panels, but it typically does. The agency is expected to make its final decision by May 15.

Hopes have been high for the vaccine, which researchers said was the first ever shown to have an impact on cancer patients' survival. Those claims were based on a three-year study, released early in 2005, of 127 men with

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