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Provenge (sipuleucel-T) manufactured by Dendreon corporation is the new therapeutic immunotherapy for prostate cancer patients with an advance metastatic tumor. The therapy was approved last April 29, 2010 by the U.S. Food and Drug Administration allowing 12 manufacturing facilities in New Jersey to operate. During the annual meeting of the Genitourinary American Society of the Clinical Oncology on 2010, Doctor Philip Kantoff said that the study is considered to be the first large controlled clinical trial that showed an immune system based therapy that extended the lives of cancer patients. Recently, Dendreon's 36 manufacturing facilities in New Jersey were approved by the U.S. FDA allowing the company to increase Provenge production supply supporting the 12 manufacturing facilities that was already been approved last April of 2010.

Provenge is an autologous type of cellular immunotherapy that halts and delays prostatic tumor growth by targeting prostatic tumor antigens. This type of immunotherapy is designed to improve the prognosis and quality life of patients with advance and recurrent prostate cancer who are resistant to hormone therapy as well as to other treatment modalities. This therapy is believed to prolong the survival rates of metastatic prostate cancer patients. According to Dr. Daniel George, director of the Genitourinary Oncology, Provenge has the largest reported survival benefits in patients with asymptomatic (no symptoms) or the minimally symptomatic metastatic prostate cancer.

Provenge therapy works by collecting the patient's white blood cells and expose them with a prostate specific antigen known as prostatic acid phosphatase. These cells are incubated with the antigen that is designed to attack the prostate cancer when injected back to the patient. As it is inside the body of the patient, the antigen instructs the immune system to attack and destroy the cancer cells. This therapy is designed to induce an immune response against prostatic acid phosphatase (PAP); an antigen expressed in most prostate cancers. Provenge therapy is the first among the new class of therapeutic therapies that belong to an autologous cellular immunotherapy; it is a personalized type of immunotherapy treatment that makes use of the white blood cells of each patient. According to the Dana Farber cancer institute investigators, Provenge therapy marks the beginning of the new era in which patient's own immune systems become part of the therapeutic arsenal against cancer.

Men who are not responding to hormonal therapies and who have metastatic prostate cancer as well as the patients who experience little or no cancer-related pain having efficient organ functioning are candidates for the therapy. Provenge is administered thru infusion via the intravenous veins of a person. It is given at three doses having two weeks range of interval. 512 patients with advanced metastatic prostate cancer as well as the patients who were resistant to hormone therapy were enrolled to the clinical study of phase 3 trial conducted at the cancer treatment centers. Randomly, patients were given with Provenge and an inactive placebo. Compared to the patients who received the placebo pills, Provenge extended the patient's median survival by 4.1 months and has reduced the overall death rate by 22.5 percent. According to Dr. Mitchell Gold the president of Dendreon Corporation, the significant 4.1 month median survival benefit Provenge demonstrated a representation of a major milestone in the treatment of the metastatic castrate resistant prostate cancer.

The common adverse reactions reported during the safety evaluation of 601 patients who underwent the Provenge treatment or the leukapheresis (extraction and incubation of white blood cells) procedure were fatigue, chills, fever, back pain, nausea, headache and joint ache. Critical adverse reactions that were reported in patients receiving Provenge include acute infusion reactions and cerebrovascular events e.g. stroke. Indications of infusion reactions include chills, difficulty of breathing, dizziness, hypertension and vomiting. The majority of the adverse reactions were mild to moderate in severity.

According to Dr. David Penson, a professor of the Urologic Surgery at Vanderbilt University Medical Center, the approval of Provenge represents significant advancement in the care of men with advanced prostate cancer. Provenge now offers new treatment of choice among the few treatment options available. "The approval of Provenge, as the first autologous cellular immunotherapy, represents a new significant scientific and clinical advancement for the treatment of prostate cancer," said Philip Kantoff, Medical Doctor and Chief of the Division of Solid Tumor Oncology, Chief of Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School.

Urieash Ul is a prostate cancer health expert who has been providing people relevant information about prostate cancer. You can visit his site to learn more about prostate cancer.

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On March 30, 2011 the U.S. CMS (Centers for Medicare and Medicaid Services) insurance program announced a proposal of full coverage payment of Provenge (Sipuleucel-T) therapy for the advanced metastatic stage prostate cancer patients. Along with its proposal, the insurance said there is an adequate evidence to pay for the expenses but for now the agency is still weighing the benefits of the therapy treatment and the final decision is expected by June 30 of next year. An advisory panel in the United States also backed Provenge by suggesting that the available data showed by the Dendreon Corporation could help patients. It is certainly a cause for concern when people see the cost of expenses of the treatment; many are considering the cost and benefits as well as its guarantees with regards to prolonging survival rates. This article wishes to provide readers information about Provenge therapy and the role of the CMS agencies.

Provenge (Sipuleucel-T) is a type of immunotherapy that is designed to treat and improve the lives of patients with an advance and recurrent prostate cancer who have become resistant to hormone therapy and who are non-respondent to other treatment modalities. This therapy works by obtaining the white blood cells of a patient and is incubated to a specific prostate antigen to specifically target the tumor when it is returned back to the body. This therapy induces an immune response against the prostate tumor. Provenge therapy costs $93,000 for three infusions given at a one month course of duration.

Provenge was approved by the Food and Drug Administration last April 2010. Data studies showed that Provenge increases survival by 4.1 months on average. According to Dr. Mark Scholz, a California based prostate oncologist and one of the public speakers urging for the CMS support for Provenge, "Provenge is a new agent that is clearly beneficial for patients". Patients, doctors and Dendreon Company urge the Medicare's advisers to pay for the high cost of therapy. Medicare payment coverage could also encourage other private insurances to pay for the expense. Aetna Inc and Humana Inc and some other health agencies have already agreed to pay for the therapy. According to the consensus analyst forecast data from Thomson Reuters, Provenge could see more than $2 billion in global sales by 2015.

The question left for us now is that who is really gaining the benefit, is it the company, the hospital, the doctors or the patients? Provenge therapy is needed by patients who have become resistant to other treatment modalities, this are the patients who have tried everything and spent everything just to lengthen their life frame. Living in this world, the cost of money does not amount to every second of our lives. Provenge is a chance given to the patients' nearly approaching death and the high cost of treatment can never amount to the happiness of spending our time with our families, friends and loved ones.

Urieashashlu Ul is a prostate health expert who has been providing people relevant information about prostate cancer treatments. You can visit his site to learn more about the prostate cancer treatments.

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