Provenge Now Campaign launched
A site to advocate for “Provenge Now!” has been launched. Provenge is Dendreon’s immunotherapy for prostate cancer, which was approved 17-0 for safety and 13-4 for efficacy by an FDA Advisory Committee vote March 29th this year. On May 9, Dendreon announced that FDA has sent them a “Complete Response Letter,” commonly called an approvable letter, requesting more data. Dendreon CEO Mitchell Gold said “The FDA has requested additional clinical data in support of the efficacy claim.”
As Dendreon’s stock began plummeting, shareholders on investorvillage.com brainstormed about how to hasten FDA approval of Provenge. In their calls for “action” and “activism” investors are sounding like prostate cancer patients a decade ago. Now, as investors post under subject lines like LET’S TAKE ACTION, several prostate cancer organizations and one physician — Us TOO, Prostate Health Education Network (PHEN), Prostate Cancer Research Institute, Malecare, Survivor’s Celebration, Mark A. Moyad, M.D., M.P.H., University of Michigan Medical Center, Virginia Prostate Cancer Coalition and Raise A Voice — are stepping forward to advocate for the drug. On the new campaign website they write:
Provenge Now is a patient advocate initiative to gain immediate FDA approval for the first ever active cellular immunotherapy treatment for prostate cancer. Survivors hope to extend their lives with a better quality with this new landmark treatment. Provenge is a symbol for a new era in prostate cancer treatment.
Provenge is the first immunotherapy vaccine treatment to complete phase III clinical trials and to demonstrate both safety and substantial efficacy for prostate cancer. It was recommended by an FDA advisory panel for approval. The panel voted 17 - 0 that the treatment was safe and 13 - 4 that it demonstrated substantial efficacy. In a surprising decision on May 8 the FDA asked for additional clinical data potentially delaying Provenge approval for a number of years.
Prostate cancer patients are demanding approval of Provenge Now. Survivors will petition Congress for immediate approval. Plans are to assemble for meetings in Washington, D.C. on June 4 and 5.
The new website is called http://www.provengenow.org
I agree siccio! If this was HIV we would of had Provenge years ago. The Chemo docs are on the take and the internal FDA politics stink. We must band together and fight!
Comment by tl — May 19, 2007 @ 10:33 pmOutstanding that investors, patients, and advocates can work together for the common good of seeing this new therapy approved. Less than a 1 in 40 chance that the survival benefit (34% of men on therapy were alive at 36 months vs. 11% of placebo) was due to chance and the FDA, for the FIRST TIME in its history (and it’s a sordid history) overturns an advisory committee that recommended approving the therapy and bringing choice and hope to patients. The FDA said “no” to hope and choice and “yes” to politics as usual. Let’s change that! PROVENGENOW.ORG!
Comment by sriccio — May 18, 2007 @ 3:39 pm