Amid the stock sell-off, a bright spot appears and, of all things, it turns out to be Dendreon, the controversial and much-maligned little company that continues to press ahead with its Provenge prostate cancer vaccine.
In a statement, Dendreon says an independent data monitoring committee found Provenge reduced the risk of death by 20 percent compared to placebo in a late-stage trial of 500 patients - and its stock surged. The interim analysis also found no safety concerns and recommended the study continue.
However, for Dendreon to pass muster with the FDA, Provenge will have to reduce the risk of death by 22 percent, and the final results won't be available until mid-2009. And so the waiting game for Dendreon investors and would-be Provenge patients continues.
In May 2007, the FDA issued an "approvable letter" and asked for additional data - the IMPACT study was in response to the request for survival data. The vaccine, which has been the subject of enormous controversy, earlier failed to show that it slowed the progress of advanced prostate cancer in two key trials (back story here and here).
12 Comments
The FDA needs to do the humane thing and approve Provenge now.
In July 2007 CareToLive filed a petition on behalf of cancer patients, with the FDA, docket no. 2007P-0297/CP1.
That petition asked the CBER division of the FDA to reconsider its failure to grant a license to Provenge.
Now there is additional data that shows Provenge is safe and effective. That additional data should be enough for the FDA to grant the Petition and reconsider.
22% versus 20% are you kidding me...these are real people with real families we are talking about!!!!
Jesse Goodman of CBER said in a January letter to CareToLive that they were actively considering the petition and had not yet decided it. Now they have more positive data to help them decide....in the name of humanity they should grant the peition and reconsider.
Too bad the anchors won't really stand up 2 cancer and stand with us to call for approval of Provenge for the patients and the for the future of immunotherapies, that will advance the war on cancer.
Ed,
Who are the 2 voting members on the Provenge FDA A/C panel who cast "YES" votes on safety and "NO", Provenge did not "establish substantial efficaccy"????
Those same two physicians also wrote "CONFIDENTIAL" letters to the FDA--leaked to a non-peer reviewed publication run outta a Washington home basement, lobbying AGAINST the approval by the FDA of Provenge in the weeks AFTER the highly positive A/C meeting.
Don't those two physicians also participate in a number of various companies CHEMO treatments for prostate cancer?
Don't those two physicians also allegedly have substantial UNdisclosed-to-the-FDA Conflicts of Interests?
Didn't today's very positive Interim data, show Provenge has a 20% fewer death rate than the "Control" arm who patients are treated with those physicians CHEMO treatment, Taxetore, and who can also switch over to receiving a lower dose Provenge after their disease progresses? So, Provenge is not only competing against Taxetore, but also against itself?
Haven't, on average, 83 men died each and every day from prostate cancer?
Since "Black Wednesday, when the FDA delayed Provenge approval, 515 days have passed as have 42,745 men died.
Aren't those so-called reknowned CHEMO doctors named Maha Hussain of Univ of Michigan and Howard Isadore Scher of Sloan Kettering?
Wondering how those two so-called physicians are feeling about their actions today with the release of very positive data from this 3rd Phase III clinical trial?
And, did you notice company guidance for Final results apparently are a bit earlier than previous guidance? Today, they said "mid-year 2009" for Final.
Thanks for keeping this tragedy in your reader's views with honest and fair reporting!
APPROVE Provenge NOW and save 83 men per day from a horrible death!
Ed, As an advanced prostate cancer patient I want to thank you for your courage in writing the truth about Provenge. 20% as opposed to 22%, I beg the FDA to grant at least a "conditional approval" on Provenge so men like me can access this immunotherapy. Please allow us access to a safe and effective therapy that will enhance what life we have left. On behalf of myself, my family, my friends and all the men in my position...DO THE RIGHT THING, APPROVE PROVENGE NOW!!! May God Bless all those who fight to right this terrible wrong. Ted Girgus
My Dad died waiting for Provenge. Like others with this disease, it was heartbreaking for our family to sit there and watch an otherwise vibrant 65 year old man wither away and endure horrible suffering that ended in a painful death 8 months later.
So yes, I get a bit emotional when I think of the fact that 1 in 5 men with terminal prostate cancer won't get more time with their families and will have to go through what we and many others have been through all because of 2%.
20% instead of 22%? For God Sake!
We'd like to of had that chance for Dad. For us and many others this isn’t just an academic exercise. Real men with real families are dying while they wait. From here the decisions of the FDA look capricious and mean spirited. Here is a treatment that continues to show positive results with little to no discernable downsides as compared to the alternative standard treatments and yet we wait to hit just a little higher target.
For our family it was too long a wait.
Respectfully, Stephen Study
Ed, Im 44 years old and have been living with this monster for 28 months. It's in my bones and in my lungs and my psa was 3216. Hormones have served me well and I am thankful for the time I have had but thier days of effectiveness may be coming to an end as psa levels have begun to rise from .09 six months ago to .80 today. It would be so wonderful to have a little hope on the horizon with provenge. Is the F.D.A. insane. What can we do when money seems to be the underlying cause of this buerocratic (sorry for the miss-spelling)wrong doing. I have felt pain I never knew existed and am starting to realize that this death sentence will be a long painful ordeal. We Prostate-Cancer patients in need of Prvenge. Thank you for putting out the word.
I`ve been thinking for months for something nice to say of our FDA. Well, excuse me, I have more thinking to do
With the latest phase 3 study coming to an early end I am hopeful for all afflicted that this drug / treatment is approved sooner vs later. I would imagin that the FDA may have a riot on thier hands if they say " nope,,,, we needed a 22% and we only got a 20%" but ya never know these guys are like accountants who have not one creative bone in thier body. let's hope for the best.
Surely they will approve Provenge THIS year (2009). If not I may not be around to reap the benefits. My oncologist tells me that I would be an idea canidate for this mediation but it may not do me much good NEXT YEAR!
I have,however, instructed my children to invest highly in Dentreon (DNDN)...either way.
IT WILL BE APPROVED SOME DAY.
You lousy crybabies. I hope you all die in hell. Provenge is bullshit and the FDA should deny approval.
The current 13 metastatic prostate tumours I have on my spine, ribs and pelvis are currently "under control" via anti-androgen therapy (after radiation). Being a young 61 years old I surf the net reading the news regarding abirterone, celecoxib, Provenge, MDV3100 et-al hoping that something will be out there when my tumours start producing their own testosterone. My bone pain is managable now and I have no desire to suffer the "miserable death" that goes with this disease.
Hi,
I whole-heartedly agree with the strong messages I have been reading with people in basically the same position as me.
I will be 80 years old this July (7-28-09). I was tested for metastasized prostate cancer on 02-25-05 (Friday) after my PSA reached 32, and found free of bone cancer. Felt pretty good. Witnessed the birth of my first grandchild later that night. The following Monday when I visited my Urologist, I got the good news and then the bad news - free of bone cancer, BUT had cancer of my lymph nodes. I was put on estrogen hormone therapy (estrogen is the inexpensive method to counter testosterone-production, which feeds the cancer cells). My PSA went down to below 1.0.
When I changed Urologist about two years later (12-15-06), he immediately put me on Lupron (30 mg. injection every 4 mo.) because of potential blood clotting with estrogen. Too late, I wound up with a blood clot in my left thigh three weeks later. The Lupron Hormone Treatment has been effective, but now my PSA has crept up to 1.2. The rate of increase up to 2.0 and higher is considered critical. Blocking Testosterone-production holds the cancer in check, up to a point.
Now, one point of concern with the low level of testosterone in my body is muscle-loss and weight-gain. I have one burning question in regard to the Provenge Therapy/Treatment, which I seem unable to find on the Internet - if I use this treatment, will my testosterone be allowed to return to its normal level.
Actually, I have more than one "burning question". How can I get on a test program? If not possible, where can I go to get the Provenge Treatment while the FDA is screwing around with only "absolutely astounding results acceptable" in the meantime and at what $ price - Sweden, Russia, Canada, Mexico?
Orville Jones
Let's all pray for John Cialis. God is the only cure for his disease. Provenge just could be the most patient-friendly treatment for our (my) type of metastatic (to bone) prostate cancer.