THURSDAY, April 29 (HealthDay News) -- Provenge (sipuleucel-T), a therapy designed to boost the immune system's ability to combat prostate cancer, has been approved by the U.S. Food and Drug Administration.
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The therapy is produced by obtaining the person's own immune cells, exposing them to a protein found in most forms of prostate cancer, then returning them to the donor. The therapy is administered three times, each approximately two weeks apart, the agency said in a news release.
Provenge has been approved for men with no symptoms or minimal symptoms of the disease, which has spread to other parts of the body and is resistant to standard hormone therapy.
In a study of 512 men, men who took Provenge had average survival of 25.8 months, compared with 21.7 months among those who didn't get the treatment, the FDA said.
Almost all recipients of Provenge had an adverse reaction, most commonly chills, fatigue, fever, back pain, nausea, joint pain or headache. About 25% of recipients suffered more serious side effects, including stroke or a serious reaction to the injection, the agency said.
Behind skin cancer, prostate cancer is the second most common cancer affecting men in the United States. Last year, 192,000 cases were diagnosed and some 27,000 men died from the disease, the FDA said, citing U.S. National Cancer Institute statistics.
Provenge is produced by Seattle-based Dendreon Corp.
-- Scott Roberts
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