Over the last year or so we have seen a marked change in the treatment landscape for men with castrate resistant advanced prostate cancer. The FDA has approved sipuleucel-T (Provenge), cabazitaxel (Jevtana) and last week it also approved abiraterone (Zytiga). This changed landscape of multiple treatment options creates new problems, of course good problems. Prostate [...]
The battle to make sure that Provenge is available nationally (in the United States) to all men who meet the FDA approval requirements is continuing. We have made great steps through the “noise” that the community has made to date. We have successfully reached, what I believe is, the final step in insuring that Provenge [...]
On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]
The Centers for Medicare and Medicaid Services (CME) decided to review their policies pertaining to paying for Provenge, which costs $93,000 per man. Since the hearings which were held a number of months ago, we have not heard any feedback. Despite this, most of the regions have been paying for the treatment, however there have [...]
Malecare has an on-line support group for men with advanced prostate cancer; their loved ones and caretakers. Today, there was a post on the support group where one of the participants shared their recent experience with Provenge, including some very specific recommendations for anyone else thinking of having the treatment. You can join us by [...]