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Home News and Update Year 2010 FDA approves prostate cancer vaccine - USA Today

FDA approves prostate cancer vaccine - USA Today

The $93,000 vaccine, Provenge, doesn't prevent cancer, unlike the polio shot or recently approved vaccines that block infection with viruses that cause most cervical tumors.

Provenge also doesn't cure cancer.

But studies show that the vaccine does help men with advanced prostate cancer live four months longer than men given placebo shots, says Philip Kantoff of Boston's Dana-Farber Cancer Institute, primary investigator of a study of 512 men.

After three years, 32% of men given Provenge were alive, compared with 23% given a placebo, Kantoff says. That's a significant benefit for men with such advanced disease, who would otherwise live only about 22 months, he says. In comparison, a chemotherapy drug called docetaxel — the standard treatment for men whose tumors don't respond to hormone therapies — helps patients live about 2.4 months longer, he says.

Many men on Provenge developed mild symptoms, such as fevers, chills and headaches. One in four patients had a serious side effect, whether they took Provenge or a placebo, as 3.5% suffered a stroke, compared with 2.6% of those on placebo, according to the FDA. Chemo can cause many serious side effects, such as fatigue, loss of appetite and dangerous infections.

More than 192,000 men are diagnosed with the disease each year and more than 27,000 die from it, according to the American Cancer Society.

Provenge works in a unique way. The series of three shots are custom-made, using a patient's own cells, and are designed to train the immune system to recognize and kill malignant cells, Kantoff says. Although the immune system naturally destroys many abnormal cells and foreign invaders, such as viruses, cancers appear to have an unusual ability to evade detection..

"It's really a very exciting point in time," Kantoff says. "It's significant for prostate cancer patients. And it's exciting from the global standpoint of opening up a whole new area of research that people have been working on for many years."

The FDA opted not to approve Provenge in 2007 after a smaller trial sent somewhat confusing signals. That study, with 127 patients, showed that Provenge helped men live longer, but didn't shrink their tumors. The results of a second, larger study, released last year, were almost identical, Kantoff says.

Although doctors still have many questions about the vaccine, many now believe it works and plan to use it soon on patients, says Otis Brawley, the Cancer Society's chief medical officer.

Dendreon, the vaccine's maker, said the vaccine will cost $93,000 for the series of three shots.

A February analysis by J.P. Morgan estimates that Provenge has the potential for blockbuster sales of $1.5 billion a year.

A growing number of health economists and patient advocates have expressed concern about the skyrocketing cost of cancer drugs. Many health plans are raising out-of-pocket costs to help cover these expenses, research shows.

When cancer drugs get too expensive, patients simply abandon them, researchers found.

A study presented in April at the Academy of Managed Care Pharmacy's annual meeting found that 29% of cancer patients with $500 or more a year in out-of-pocket costs stopped filling their prescriptions.



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