Friday, April 30

New Therapy For Advanced Prostate Cancer: Approves By U.S. FDA

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

This new therapy "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.

According to the National Cancer Institute, 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.

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

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.

Provenge is effective as per study in 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.

Patients receiving Provenge treatments has a median survival in 25.85 months as compared to 21.7 months for those who did not receive the treatment.

However, 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.
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