Provenge is the first therapeutic cancer vaccine to receive approval from the U.S. Food and Drug Administration. FDA approval means it can now be part of the standard treatment for certain prostate cancer patients, rather than being used only in clinical research studies.
As a vaccine, Provenge harnesses the body's immune system to fight cancer. Unlike preventive vaccines, which protect people from developing particular diseases, Provenge is a therapeutic vaccine which is given to people who have already developed prostate cancer.
The vaccine is produced by removing some of a patient's white blood cells, then exposing them to a protein from prostate cancer cells and a stimulatory molecule. This process primes the white cells to attack prostate cancer when they are re-injected into the body.
Provenge is approved for men with advanced, metastatic (spreading) prostate cancer that is resistant to hormone therapy.
Recently the manufacturer increased its capacity substantially. This should enable greater access to Provenge and shorten the length of the wait time.
In a large Phase III clinical trial led by investigators at Dana-Farber Cancer Institute in Boston, Provenge was found to extend the lives of patients with advanced, minimally symptomatic or asymptomatic metastatic, androgen-independent prostate cancer by an average of four to five months, compared to patients who received an inactive placebo.
The most severe adverse effects reported in the clinical trial were reactions to the infusion of activated white blood cells. These occurred in 3.5 percent of patients in the trial and included chills, fever, fatigue, difficulty breathing, dizziness, headache, muscle ache, nausea, and vomiting.
Patients should check with their oncologists to find out if they meet the criteria for receiving the vaccine.
Approximately 12 patients per month.
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