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 through 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.
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