Provenge is a very iffy drug. The FDA is doing due diligence with it and is delaying it’s release on the market–There appears little value in this drug as noted below.
Tested against a placebo, Provenge, a prostate cancer vaccine manufactured by Dendreon, showed a survival benefit of about 4 months–barely statistically significant, given that the study included just 127 patients. Another study showed a survival benefit of 3.3 months, not statistically significant.
The vaccine was not tested against the effective chemotherapy for prostate cancer, taxotere, so we don’t know if it is more effective. It was not tested in patients who already received taxotere, so we don’t know if the effect of these agents will be additive.
For this we will pay an estimated, by financial companies, (I haven’t found a retail price yet) $30,000/year or more. Is it worth it? Who knows, the data is inadequate to reach a reasoned determination..
For the drug developer a real study of efficacy might be embarrassing. Thus they test against no treatment in small numbers and hope for at least an ambiguous result.
