FDA May Finally Approve Provenge Prostate Cancer Vaccine

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The FDA may approve a revolutionary new vaccine this week which would extend the lives of prostate cancer patients with fewer side effects than traditional therapies. The vaccine, called Provenge, was developed by Dendreon Corporation of Seattle.

Provenge works by stimulating the body’s own immune system to fight cancer cells. It has not been shown to cure the cancer, and will not replace traditional therapies, but the drug was shown in early clinical trials to allow men with advanced states of prostate cancer to live, on average, 4 ½ months longer.

During the clinical trial, more than 500 men with advanced prostate cancer that had metastasized to other parts of the body were divided into interventional and control groups. Of the men who got Provenge, nearly a third were still alive in three years, compared with less than a quarter of those who got placebos. Only mild side effects such as flu-like symptoms (chills and stiffness) were reported.

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That may not sound like much, but it's significant for a group of men with few options, said Dr. Celestia Higano, a prostate specialist at Seattle Cancer Care Alliance who helped oversee the clinical trials.
Dendreon’s hope is that the drug will eventually show promise in patients with earlier stages of prostate cancer and that the technology behind the vaccine may have applications to other kinds of cancer.

"It gives me a lot of hope," said University of Washington researcher Dr. Nora Disis. "I think the Dendreon vaccine will be the first in a long line we'll see approved over the next eight years or so." More than 100 clinical trials are underway on cancer-treatment vaccines.

During the treatment, doctors remove the patient’s white blood cells and treat them with the medication before placing them back into the bloodstream. The treated cells then look for and destroy cancer cells without touching healthy cells.

The Provenge vaccine was first presented to the FDA in 2007 but failed to be approved, even though the advisory panel voted overwhelmingly in favor of the treatment. Should the drug pass this week, treatment will not be cheap. Reports by ABC News say that one course of Provenge may cost between $50,000 and $75,000.

Prostate cancer strikes nearly 200,000 American men every year and kills 27,000, according to the CDC.

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