FDA Approves A Cellular Immunotherapy For Men With Advanced Prostate Cancer

The U.S. Food and Drug Administration approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge 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.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“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, M.D., 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, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals. Read more

“Vaccine” For Advanced Prostate Cancer Wins FDA Approval

The US Food and Drug Administration (FDA) on Thursday approved a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease; although described as a “vaccine” the new therapy, called Provenge, treats rather than prevents prostate cancer.

In a statement the manufacturer, Seattle-based Dendreon Corp, described Provenge (sipuleucel-T) as the first therapy in a class known as “autologous cellular immunotherapies”, marking a significant step in personalized treatment for cancer.

According to Dendreon, Provenge is designed to treat:

“… asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC).”

Dr Karen Midthun, acting director of the federal agency’s Center for Biologics Evaluation and Research, explained that Provenge offered:

“A new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available.”

In the US, prostate cancer is the second most common cancer in men, after skin cancer, and mostly affects older men.

According to figures from the National Cancer Institute, last year in the US there were some 192,000 new cases of prostate cancer and 27,000 deaths to the disease. Read more

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