U.S. FDA approves new therapy for advanced prostate cancer

WASHINGTON, April 29, 2010 (Xinhua) --

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

Provenge is 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," Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said.

Provenge, an autologous cellular immunotherapy designed to stimulate a patient's own immune system to respond against cancer, is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months.

The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Meanwhile, almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache.

The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke.

Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Editor: Xiong Tong

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