FDA Approves Prostate Cancer Vaccine

A therapeutic vaccine aimed at preventing the spread of advanced prostate cancer in men has been approved by the US Food and Drug Administration (FDA).

The approval of the medication called Provenge is limited to the treatment of prostate cancer with little or no symptoms that has spread to other parts of the body and is resistant to standard hormone treatment.

According to the American Cancer Society (ACS), more than 192,000 new cases of prostate cancer are diagnosed in the US each year, and 27,360 men die from the disease.

Prostate cancer is the most common form of cancer diagnosed in American men, after skin cancer. More than 2 million American men who have had prostate cancer at some point are still alive today.

New Treatment Option Welcomed

Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, says Provenge provides a new treatment option for men with advanced prostate cancer who have limited effective therapies available.

Experts say the medication's approval could be a milestone against the disease and cancer in general.

Provenge appears to extend survival in men with advanced prostate cancer, and it does so without the serious side effects linked with chemotherapy, radiation, and hormone therapy.

The vaccine is made from the patient's own white blood cells. Once removed from the patient, the cells are treated with the medication returned to the patient's blood. These treated cells then cause an immune response, which in turn kills cancer cells, while leaving normal cells unharmed.

The vaccine was studied in men with advanced prostate cancer who had already failed standard hormone treatment. The only side effects were mild flu-like symptoms, according to the report.

The vaccine is not aimed at preventing prostate cancer in men who have not developed the disease, and it is not a cure for those who have it, says Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the ACS.

"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 says.

Still, says Dr. Lichtenfeld, it might prove possible to use Provenge in the earlier stages of prostate cancer, where it might be even more effective.

"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 explains.

Physicians Need More Information

Dr. Mark Soloway, professor of urology at the University of Miami, says physicians need new therapy options for their patients.

The big question, according to Dr. Soloway, is when to use Provenge. Whether it should be used before chemotherapy or hormone therapy is not clear, he says.

"There are problems with Provenge," notes Dr. Soloway. "One is that it's very cumbersome because patients have to provide their white cells, and I think that's on a regular basis. And two, it's likely to be very expensive."

Costs are expected to total $75,000 for the full regimen, experts say.

However, he says, "Once it's approved, it's on the market, and with proper informed consent, you can use it for localized [early stage] prostate cancer. Whether insurance companies will pay for it is also not known."

Always consult your physician for more information.