The FDA Has Approved Provenge

Provenge has finally received the long awaited approval from the FDA!!! We all celebrate and look forward to benefiting from its potential to extend our life.

Provenge is the first immunologic therapy ever approved in the United States to treat cancer. (In Russia, Antigenics has received approval for an immunological treatment for kidney cancer).

The FDA’s approval of Provenge is very narrow, just for men who have castrate resistant metastatic, asymptomatic prostate cancer. This means that you must have prostate cancer tumors outside of the gland and you are no longer responding to hormone therapy.

Despite this limited approval, I believe that the first year’s demand for the treatment will out strip the ability of Dendreon (the bio-tech company that developed Provenge) to accommodate all the men who wish to get the treatment. Although there will be doctors attempting to write “off label” prescriptions for the treatment, I do not expect that many men, if any, will be successful in obtaining the treatment if they are outside the very strict approval parameters.

Dendreon has been aware of the potential initial supply problems they will face in meeting the very early demand. The company is very sensitive to this issue and has taken the lead in trying to find ways to mitigate the problem. Despite the fact that they had not received FDA approval, they are well into a large building program that includes expanding their physical plant in three separate locations in the United States as well as hiring and training a large cadre of workers to so they will be able to hit the ground running. I applaud Dendreon for their willingness to “stick their necks out,” even before the FDA approval.

Hopefully, within the first year, they will be able to catch up to the demand along with continuing additional trials to demonstrate that Provenge in earlier disease can also offer survival extension.

Initially, Provenge’s availability will be limited solely 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 Dendreon has set up a network of 50 infusions sites (this number will be expanded in the future) throughout the United States so any man in the States will be able to access the treatment.