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The U.S. Food and Drug Administration today 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.
"We are excited that there is now another option for treatment for men with advanced disease and excited for the future as immunotherapy research continues and expands", said Wendy Poage, President of the Prostate Conditions Education Council.
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.
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.
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.
Although, access to the treatment will be minimal for sometime as processing centers are built we are thrilled that the University of Colorado and 49 other centers around the country, who were involved in the clinical research, will be among the first with access to the product.
To learn more about
the PCEC's prostate health recommendations and the value of prostate
cancer screening, visit www.prostateconditions.org.
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7009 S. Potomac Street, Suite 125 - Centennial, CO 80112
1-866-4PROST8
www.prostateconditions.org
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National Council Physicians
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E. David Crawford, M.D.
University of Colorado
David G. McLeod, M.D Walter Reed Army
Neal Shore, M.D.
Grand
Strand Urology
Frank
Staggers, M.D.
NMA
Nelson
N. Stone, M.D.
Mount Sinai
Allan Partin, M.D.
Johns Hopkins
Daniel
Petrylak, M.D.
Columbia-Presbyterian
Mark Moyad, M.D.
University of
Michigan
Mack Roach, M.D.
University
of Calif. SF
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