MB: The FDA has approved a new therapy for certain men with advanced prostate cancer. It's called Provenge (sipuleucel-T), and it's manufactured by Dendreon Corporation. Provenge, an autologous cellular immunotherapy, is intended for men with asymptomatic or minimally-symptomatic prostate cancer that's metastasized and is resistant to standard hormone treatment.
AR: Provenge is designed to stimulate the patient's own immune system to respond against the cancer. Each dose of Provenge is manufactured by first obtaining immune cells from the patient's blood using leukapheresis. Then the cells are exposed to a protein linked to an immune-stimulating substance that's found in normal prostate tissue and in most prostate cancers. Finally, the cells are infused back into the patient to treat the cancer.
MB: The effectiveness of Provenge was studied in 512 patients enrolled in a multi-center trial. Patients receiving Provenge survived about four months longer than those not receiving the treatment. Almost all the patients receiving Provenge had some type of adverse reaction, most of which were mild or moderate. About 25% of the adverse events were serious, including some acute infusion reactions and stroke.

标题
Prostate Cancer Immunotherapy (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
The FDA has approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer.

Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration

Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration