Vanessapiper-givler@cis-partners.com
The FDA is now reviewing the submission of the prostate cancer vaccine Provenge by the Seattle-based company Dendreon. The FDA has not yet approved any cancer vaccine submission, but Provenge has been recommended for approval by the FDA advisory committee. In 2007, the FDA decided to wait on giving the vaccine approval until the IMPACT trial was completed [1]. Provenge is for the treatment of one of the most common epithelial cancers – prostate cancer.
Dendreon has a different approach to the prostate vaccine process. They are processing the patient’s own immune cells which they then nourish with a prostate protein, prostate acid phosphatase. The processed cells are then transfused back into the patient, with the hope that the T-cells will kill the prostate cancer cells. The Phase III clinical trial showed survival benefit higher than what has been seen in the past in men with prostate cancer. The study showed that men who received Provenge had a 34% chance of being alive compared to those men who did not receive Provenge, who had less than a 10% chance [3]. It was also revealed that Provenge has shown the greatest results when combined with other cancer drugs such as chemo [2].
“The vaccine augments [drug] treatment; it does not replace it,” said Andrew T. Parsa, M.D., Ph.D., an assistant professor in the Department of Neurological Surgery at the University of California. He goes on to state that he “sees two major points to make with the vaccine. One, it is virtually nontoxic. You are using your body not drugs to fight cancer. Two, it is not a cure, per se, but you are mobilizing an army to help with whatever treatment regimen you have chosen”. [1]
The other advantage of Provenge is that the side effects are minimal in that patients are only experiencing a fever and chills. The vaccine treatment helps the immune system to work better so the side effects are similar to the effects of the body mounting an immune response against the flu. This is great news for prostate cancer patients who may have something new in the near future to help them battle this disease.
Sources:
1) http://bit.ly/VChdN
2) http://chetday.com/provengeprostatecancer.html
3) http://bit.ly/cACLlC
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