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FDA Approves New Prostate Cancer Therapy

A new treatment has been approved for certain men with advanced prostate cancer.

Called Provenge (sipuleucel-T), the treatment stimulates a patient’s own immune system to respond against the cancer. The Food and Drug Administration (FDA) announced its approval on April 29, 2010.

Provenge treats prostate cancer that is either asymptomatic (meaning the disease is present but the patient experiences no symptoms) or minimally symptomatic, and which has spread to other parts of the body and is resistant to standard hormone treatment.

Provenge, made by Seattle-based Dendreon Corp., is administered intravenously in a three-dose schedule given every two weeks.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” says Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research.

In studies involving 512 patients, those receiving Provenge treatments lived, on average, about four months longer (25.8 months) than those who did not receive the treatment (21.7 months).

Almost all of the patients who received Provenge had some type of side effect (adverse reaction). Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache, and headache. The majority of adverse reactions were mild or moderate in severity.

Serious adverse reactions, reported in about one-fourth of the patients receiving Provenge, included stroke and some acute infusion reactions.

Prostate cancer ranks second to skin cancer as the most common type of cancer among men in the United States. It usually occurs in older men. According to the National Cancer Institute, about 192,000 new cases of prostate cancer were diagnosed—and about 27,000 men died from the disease—during 2009.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: May 4, 2010

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