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Analysts expect the product to reach blockbuster sales status -- over $1 billion -- by 2016, as the company expands production capacity.
Each regimen of Provenge must to tailored to the immune system of the patient using a time-consuming formulation process.
Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to rev up the immune system. The resulting "vaccine" is given back to the patient as three infusions two weeks apart.
Initially, Dendreon will identify Provenge patients through the 50 medical centers that helped test the drug. But researchers have been told the company will only be able to provide vaccines for a few patients at each site per month.
"There are going to be a lot of patients that want it and there will be limited resources as they are getting this up and running," said Dr. Deborah Bradley of Duke University School of Medicine
About 192,000 new cases of prostate cancer were diagnosed in 2009, and 27,000 men died of the disease, according to the FDA. Prostate cancer most often affects older men.
Side effects of Provenge are relatively mild, such as chills, fatigue, fever, and headache. By comparison, side effects of chemotherapy typically include hair loss, nausea, anemia and diarrhea.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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