The following was submitted to the FDA in support of the development of additional treatments for men with advanced prostate cancer, including Provenge.
The advocates of “Raise a Voice”, a grass roots initiative for advanced prostate cancer, would like to express our appreciation for the opportunity to present comments at the Cellular, Tissue and Gene Therapies Advisory Committee meeting on March 29, 2007.
We respect and appreciate the importance and difficulty of the FDA’s current process towards decision on approval of Provenge (sipuleucel-T).
Given the following points, we would like to reaffirm our position on the need for additional effective treatments with fewer side effects for advanced prostate cancer.
* The very favorable risk-benefit ratio of Provenge
* The survival data discussed at March 29th meeting
* The necessity for additional effective treatments for advanced and hormone-refractory prostate cancer based on the current US death rate of approximately 27,000 men a year
My wife and I live in a retirement community that has many prostate cancer victims who desperately need Provenge to give them hope for extended longevity. Nice work.
I feel provenge is a much better treatment for advanced protate cancer than anything out there today.I am for one hundred percent full approval without delay.
If the Government cleaned house at the SEC and canned the bunch of them and brought some new blood, it would be honest for a while anyway.
Provenge–36 out of 100 still alive after 36 months
Placebo– 11 out of 100 still alive after 36 months
Provenge and Taxotere combo 15 months longer average survival longer than Taxotere alone. And, Taxotere the only other treatment.
If this Provenge is not approved and Manipulated off the board by big money—well what can a decent human say.
What Provenge has shown is truly remarkable results for late stage prostate cancer. Very minimal side effects and a 300% increased chance for 3 year survival, when most men with HRPC don’t live more than 20 months after hormone treatments fail to continue working.
Provenge absolutely needs to be approved right away, and I hope dearly it will be shown effective in early stage PC as well. This is exactly the kind of therapy the drug industry need to be working on. Not more chemos but active immunotherapies. They are now shown to work well, so lets get more of them into study and into the market.
The FDA will make a powerful, positive statement by approving Provenge. Money will flow into new areas of research and that is exactly what we need. I hope the FDA understands how important this is. It is important for PC patients and it is important for the advancement of medical sciences in general.
I have worked in the cell cancer therapy field for more than 5 years. Dendritic cell therapy has great potential as evidenced by Dendreon’s “Provenge”. However, what Dendreon has accomplished is only the beginning. Minor modification of Dendreon’s stategy has the capability of curing many thousands of cancer patients (prostate, breast, and renal). Let us all hope and pray for a positive recommendation from the FDA so that this novel therapy may be fully developed to reach it’s full potential and revolutionize cancer therapy.
I am at metastatic bone cancer due to advanced prostate cancer which had invaded the prostate wall 9 yrs ago. I have had chemo, radiation, Lupron, Taxotare, and any other treatment available at Moffitt Cancer Center. What is the chance of this new treatment working for me now? Any one with a solid answer?
Don, As of this moment Provenge is not available to anyone, other then through their on-going clinical trial, as the FDA failed to approve the treatment. The FDA has requested additional data about its efficacy and about their manufacturing process.
The approval that has been requested is for HR prostate cancer where the survivor does not have symptoms. If it were approved then it might be possible to have your doctor write an off label prescription.
I am not aware of any research where Provenge has been used after chemo. Dr. Daniel Petrylak has conducted a study where Provenge was used before chemo. He found a significant increase in life extension.
Joel