Prostate cancer vaccine approved

The FDA approved the first ever cancer vaccine Thursday. Provenge made by Dendreon Corp. of Seattle, Wash. is for men with advanced prostate cancer. The vaccine uses the male immune system to fight tumors.

The FDA said Provenge is for “asymptomatic or minimally symptomatic prostate cancer” that has spread beyond the acorn sized gland but is resistant to the standard hormone treatment currently used.

Mitchell H. Gold, president and chief executive officer of Dendreon Corp.

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

The vaccine is designed to stimulate a patient’s immune system to attack the cancer cells. Provenge is made using immune cells obtained from the blood. Those cells are exposed to a protein in most prostate cancers and then returned to the patient.

Three doses are given by IV at two-week intervals.

In a trial of 512 men with metastasized prostate cancer, almost all of the patients had adverse reactions that were mostly mild or moderate. Among the most common reported were fever, fatigue, nausea, and headache. About one in four patients had serious reactions that ranged from reactions to the IV to stroke.

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