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| Dear FDA: We prostate cancer patients with challenging cases have been aware of Provenge research for some years now. In 2003 and later years the National Conference on Prostate Cancer series explained this promising vaccine. This news was like the far off bugle of the cavalry coming to the rescue of our beleagured forts, drawing nearer as the years passed, and whetting our expectations. Now in June we not only have learned of Provenge's notable success in extending survival, which merited a one-sided vote of confidence from the review panel, but from the recent AUA conference we have also learned that patients taking both Provenge and docetaxel achieved a median survival of a breathtaking 34.5 months, more than a year longer than the 20.9 months predicted and the 20.2 months for the ten patients who got docetaxel only following placebo. This potent comb promises to revolutionize the way late stage prostate cancer patients think about chemo, finally and firmly tilting the cost-benefit ratio toward substantial benefit. I'm sure that virtually all of us who are active in support groups across the nation know of men who need Provenge now. If Provenge is not available, it's a near certainty that many thousands will die at least a year earlier. Moreover, for patients who won't accept chemo, the opportunity for a survival advantage plus a mild side effect profile will be lost for many thousands now enduring late stage prostate cancer. Delay in approval is extremely frustrating. We recognize that the FDA needs to see more data before a permanent approval. However, informed patients desire to take the efficacy risk upon themselves before final approval. It is our fervent hope that some type of interim approval be granted that would permit Dendreon to market Provenge. Sincerely, J.W. I want to add my name to your list to show support for men with |
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