I have received a number of e-mails from men who are both frustrated that Provenge is not yet approved and who are frustrated that even when approved they will not qualify to get the treatment. I understand the frustration and feel the same way.
The first question is will the FDA approve Provenge? Only time will tell, but many of us are very optimistic. The FDA has announced that a decision will be announced prior to May 1, 2010. So will hopefully know in the very near future.
If the FDA does finally approve Provenge, the approval will be limited to men with androgen independent prostate cancer (hormone resistant) because that is the specific disease stage that the clinical trials evaluated. Over time, there is no reason to believe that some doctors will write “off label” prescriptions for Provenge, but there will be a serious question about whether insurance coverage will be extended to “off label” use.
Provenge’s availability will also be limited to the United States. The FDA approval will not effect approval in any other country. Provenge is custom made for each man by a process that modifies a man’s own personal blood product. The modification process and reintroduction of the processed blood must be completed in a matter of a few days, so it is imperative that a man lives in easy striking range to a Dendreon facility.
Dendreon, the bio-tech company that has developed Provenge still has not announced any pricing data for the treatment. Many of us believe that the three courses of treatment that the protocol requires will cost between $85,000 and $150,000, but this is pure speculation. Although this sounds like a lot of money, these costs are not out of line with other cancer treatments available in the market place.
We hope to see some clinical trials of Provenge in the near future for men with hormone dependent disease, but I am not optimistic that these trials will begin for another two to three years, at the earliest. Then, the trials will need to be continued for many additional years (more time then the earlier trials took since the men in the trials do not have disease that has progressed as far and are much healthier) to allow survival data is collected.
Dendreon, if they receive approval in the next month, will be struggling to meet the initial demand from men with hormone refractory disease who meet the approved disease criteria. I believe that the company will be over whelmed by the demand and unable to meet it for at least two years, possibly longer.
Dendreon has launched a massive building program in their plants in New Jersey, California and Georgia, but the construction will not be completed for at least another year or two. They have also been on a major hiring and training binge to prepare to cope with the expected demand. I do want to commend the company for their willingness to make the huge financial commitment they have made in both plant and personnel, even before receiving the FDA approval.
However, Dendreon will not be able to meet the initial demand for product and many of us will become frustrated while we wait.
Knowing this, I have been doing some searching for other immunological trials which could provide an alternative while we wait. There is Phase I clinical trial evaluating another immunologic therapy for prostate cancer and they are accepting men who are hormone dependent. Go to http://www.clinicaltrials.gov and search for: NCT00908258. Or you can click on this link, NCT00908258.
I discussed this trial with my oncologist who was supportive of my participating. Sadly, I was rejected from participating because of a history of an autoimmune disease and lymph node involvement (not stage D0). You might want to look into the trial and discuss it with your oncologists.
I am a strong believer in the potential of immunological treatments for prostate cancer as well as other cancers. I believe that they will provide an important future treatment alternative which when coupled with other treatments. will extend our life with a minimal degradation of the quality of life.
Joel T Nowak, MA, MSW