FDA Approves New Provenge Trial Design
3 CommentsBy Ed Silverman // March 12th, 2008 // 9:02 am
This is a rare bit of hopeful news for the many agitated prostate cancer patients and Dendreon investors, who have been angry at the FDA after the agency ignored a recommendation last spring from its own advisory panel to approve the vaccine.
The FDA has approved an amended trial design of a late-stage study, which should accelerate the expected timing of final results by about one year. UPDATE: Not surprisingly, the news sent Dendreon shares up more than 7 percent by the end of trading.
Interim results are still expected in the second half of 2008. However, final results are now expected in the second half of 2009 rather than 2010, according to a Dendreon statement. The FDA will still accept positive interim or final survival data from the ongoing IMPACT trial for an amended marketing application. Last May, the FDA issued an “approvable letter,” and asked for more data, after Provenge failed to show that it slowed the progress of advanced prostate cancer in two key trials. The IMPACT study is a response to the FDA’s request for survival data to support approval.
There was actually some good news last month, too. 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.
Nathan
Ed, I have to know something: How do you do it? It’s 9:20 in the morning and you have already posted 6 new articles for the day. Do you have other writers working for you or do you just stay up all night working?
Ed Silverman
Hi Nathan,
First, I start at 6 am EST. But I have various techniques as part of my overall approach - I read quickly and I write quickly. Over the years, I’ve trained myself to react rapidly to breaking news.
Of course, for some items, I’ve simply provided a link from elsewhere, although I may weave in a little of my own fairy dust if I have the presence of mind. Now and then, I warehouse an item or more from the previous day. And I work on those the night before.
It’s a long day, yes, but for now, it helps establish the site. From here, who knows? But it’s interesting.
Cheers
ed
Tony F
Kudos, Ed!
As usual you’re on top of all the breaking headlines in the biotech/pharma field and, despite the urgency to report a breaking story, you seem to get it right and report it fairly.
This is excellent news for terminal prostate cancer patients; the downside, of course, is the extended delay of a year or years caused by the apparent dishonesty of those who have financial and professional interests opposed to Dendreon’s Provenge. This extended delay has already allowed over 25,000 men to die from PCa at the rate of 83 men per day–many of who could possibly have been helped by Provenge–and will continue to forsake these terminal cancer patients until the FDA is satisfied about Provenge.
This is a medical situation involving dying men; we’re not talking a new type of asiprin here.
Thank You! for your continued reporting of this saga.