The SEC Probes Dendreon
8 CommentsBy Ed Silverman // July 10th, 2007 // 6:34 pm
The controversial drugmaker says in a Securities and Exchange Commission filing late this afternoon that the agency’s New York regional office wants info about clinical trials for its Provenge prostate-cancer vaccine. Dendreon described the request as an “informal inquiry.”
The letter from the SEC asks for info “related to the company’s clinical trials for Provenge, the company’s biologics license application for Provenge filed with the (FDA), and the FDA’s review of Provenge and related correspondence to and from the company, from Jan. 1, 2007 through the present.”
“The SEC’s letter notes that the request should not be construed as any indication by the SEC or its staff that a violation of the federal securities laws has occurred nor should it be considered a reflection upon any person, entity or security,” Dendreon disclosed, adding that officials intend to “cooperate fully with the SEC.”
The only thing surprising about this move is that it took so long. Dendreon shares have been gyrating all year as cancer patients and investors followed the high-wire ups and downs surrounding the vaccine, which an FDA panel unexpectedly endorsed as safe and effective. But then FDA officials were lobbied by two panel members - who held conflicts of interest - to resist approval, causing another uproar and threats made against those two dissidents.
jason
Please look up the phase 3 data and make your own decision. From the studies I have seen, this is not a more efficacious drug than the current options. We know the current meds (hormonal treatment) have been on the market for 20 years and have that safety record. Why would the FDA approve a med that is no better, and might not be as safe? I was only surprised that it got the thumbs up from the advisory panel. The FDA was in a no win situation - no approval and face scrutiny from investors and PCa patients, approve and if it blows up down the road, get blamed for rushing to approve another unsafe med. A hate to be a broken record, but look at the data and make your own decision, so far this has not looked like a breakthrough but another potentially interesting option.
Sam
jason, do you call a treatment that showed a 3-fold increase in overall SURVIVAL after 3 years (34% of Provenge were alive after 3 yrs vs 11% of the patients who took placebo) with nearly no side effects SIMILAR to chemotherapy treatment with its HUGE list of side effects that showed a much smaller smaller survival benefit?
Please read the FDA review documentation and check the presentations made at the FDA’s panel.
Or … just read Scher’s and Hussain’s UNDISCLOSED COIs
jason
Sam, where is that data? I am referring to the article that reviewed the 2 phase 3 trials. It is in: Expert Rev Anticancer Ther. 2006 Sep;6(9):1163-7. Don’t quote me, but I believed it showed 3-4 months over placebo.
Let me know where you found your info and I would love to take a second look at it.
Thanks, j
The Dude Abides
Jason, the hormones you’re referring to are used to treat HDPC. This is an earlier stage of prostate cancer than HRPC, which is the disease in the Provenge BLA and is the terminal stage of prostate cancer. That’s why it’s called hormone-resistant prostate cancer. The current direct competitors of Provenge in HRPC (if it had been approved) are docetaxel, mitoxantrone, and estramustine, which are all chemotherapy drugs. All three have severe side effects…severe enough that over half of the men with HRPC but are still asymptomatic decline these chemo drugs. A better alternative is needed.
jason
No question Dude, but the phase 3 trials I have seen are unconvincing. Did Dendreon go after Hormone refractory or dependent patients for labeling? Obviously the hormone dependent patients are a much larger pool, and the phase 3 trials showed limited benefit versus placebo. So I just want to see the data, obviously the most publicized phase 3 studies are not impressive to me or the FDA.
jason
Dude, Sam -
I had trouble navigating the FDA site easily and seeing the application - Do you guys know what indication they applied for?
Also did a quick Medline search, unable to find the article you were referencing Sam, do you have a citation on that data?
qetzal
Jason,
You can review the briefing materials, presentations, transcripts, & other docs from the FDA’s March 29-30 advisory committee meeting for this product here.
(I hope the link works. It’s for the Cellular, Tissue and Gene Therapies Advisory Committee on FDA’s web site.)
I haven’t read any of the material, but it should cover all the clinical data that Dendreon thought would support approval.
jason
Qetzal,
Thanks for the link, exactly what I was looking for! Can’t wait to look it over tonight.