Provenge: Setback In Congress, Progress In The Lab
The battle among prostate-cancer patients and investors to have the FDA approve Dendreon’s Provenge suffered a setback yesterday when a congressional committee declined to hold a hearing into the agency’s handling of the controversial vaccine. Today, however, the drugmaker released some news that it hopes will convince regulators that their decision to delay approval should be reversed.
At the American Society of Clinical Oncology meeting in San Francisco, Dendreon researchers presented data demonstrating the correlation of a measure of the cumulative potency of the vaccine with overall survival. And they claim this is “the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported.”
In two Phase III trials, D9901 and D9902A, researchers evaluated cumulative product release parameters of Provenge, including CD54 upregulation, which is a measure of product potency. The results showed that Provenge patients experienced improved survival if they received more cells across the three doses of Provenge or higher cumulative CD54 upregulation values.
“We have been able to show a correlation between patient survival and a measure of the cumulative potency of Provenge; such a correlation between product potency and clinical outcome has not been previously demonstrated with an active immunotherapy,” Mark Frohlich, Dendreon’s chief medical officer, says in a statement. “These data provide further evidence that (Provenge) is actively engaging the immune system in a clinically meaningful way that prolongs patient survival.”
Phil Vardena (Pharm. D.)
IF DNDN is able to demonstrate the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T) with overall survival, this is a “lateral” proof: Provenge works!
If Provenge were NOT to work, DNDN would NOT be able to demonstrate any correlation!
Have a nice day everyone!
Regards,
Paul
This study goes right to the heart of Dr. Scher’s criticism and worries that the Provenge survival results were merely by “chance.”
Dennis
FDA is making the biggest mistake in terms of Provenge. No side effects and prolongs patient lives. What more can you ask. Approve Provenge!!!
Bob DeVivo
Any further delay in the approval of Provenge is absurd! We now have proof that this safe treatment extends life. To continue to brutalize PC patients with chemo makes no sense.
Tony F
As of today, 23,240 men had DIED in the 9 MONTHS since the May 9, 2007 delay in approving or granting a conditional approval of Provenge…
“Hello, FDA!”
… is anyone awake at the switch?
Grant “Conditional Approval” pending the completion of the current confirmatory study… remember, you can yank your Conditional Approval at any time if any untoward event(s) come up not previously experienced.
Save our men with TERMINAL prostate cancer!!!
Kyoto27
Re the setback in Congress, as noted by a wise observor, “it is ironic this word would come down on a day when Congress could find an entire half day to berate a baseball player for taking performance-enhancing drugs. If Roger Clemens is harmed from taking these drugs (assuming for a moment he did), he (a) made his own choices and now has to live with them, and (b) he has more than enough money to buy himself some pretty nice healthcare.
Contrast that with prostate cancer patients. They don’t get a choice. The FDA took it away from them. It isn’t just one man, it’s thousands—perhaps reaching tens of thousands by the time Provenge is finally on the market.
Apparently the Senate decides where it will focus based upon not whether the issues are worthy of Congressional attention, but the likelihood of whether they can get their mugs on cable news for a few hours.
They ought to be ashamed. And we mean really ashamed.”
Ed, I hope you will also ask our Congressional friends if they feel any shame –even a little? The Provenge Story has exposed a Heart of Darkness in this country that few other stories have exposed —and the Fourth Estate has maintained –ex-the Ed Silvermans of this world, a significant silence that is as odd, as it is disturbing.