FDA OKs Advanced Prostate Cancer Therapy

WASHINGTON, April 29 (UPI) — The U.S. Food and Drug Administration announced approval Thursday of a new therapy for certain men suffering advanced prostate cancer.

The FDA said the drug, Provenge (sipuleucel-T), allows patients to use their own immune system to fight the disease. The drug is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.


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

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, the FDA said. The immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After that process, the patient’s own cells are returned to the patient to treat the prostate cancer.

Provenge, administered intravenously in a three-dose schedule given at about two-week intervals, is manufactured by the Dendreon Corp. in Seattle.

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