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