FDA approves Dendreon's Provenge

SILVER SPRING, Md. The Food and Drug Administration has approved a new biotech drug for prostate cancer made by Seattle-based biotech company Dendreon, the agency said Thursday.

The FDA approved Provenge (sipuleucel-T), a therapy that treats advanced prostate cancer by stimulating the patient’s own immune system. Each dose is manufactured by obtaining a patient’s immune cells from the blood using a process called leukapheresis. The cells are then exposed to a protein found in most prostate cancers and then returned to the patient’s body. The treatment is given in a three-dose schedule at two-week intervals.

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

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