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 with just 12 workstations operational as opposed to the 48 that are now approved by the FDA. After this approval the company claims to no longer be constrained in its ability to service all the men with advanced prostate cancer who wish to have the therapy.
Currently there are only four FDA approved treatments for men with advanced prostate cancer that have demonstrated life extension. Provenge provides the longest life extension among this group.
We all hope that this increase in capacity will allow Dendreon to end all the waiting lists of men who qualify to receive the drug, will allow for more clinical trials of Provenge with earlier stage disease and will allow Dendreon to use their technology to construct similar type of treatments for other cancers.
On Friday Dendreon will celebrate the ceremonial opening of these workstations with a formal ribbon cutting ceremony. Besides advocates, survivors and their staff many New Jersey government officials are expected to attend. I have been invited to participate as a representative of the advocacy and survivor community in the ribbon cutting ceremony.
Dendreon anticipates additional FDA clearances by the middle of this year, 2011, to start producing Provenge at its facilities, currently under construction in the Los Angeles and the Atlanta metro areas.
Joel T Nowak, M.A., M.S.W.