Provenge® (sipuleucel-T) and Prostate Cancer
June 3, 2007 by Gloria Gamat
Filed under Diseases & Conditions
The cancer immunotherapy Provenge® (sipuleucel-T) is currently being investigated in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but whose cancer have not yet metastasized.
Results of the said study as presented by Oregon Health & Science University Cancer Institute revealed:
- sipuleucel-T did not significantly delay the time it took for a patient’s PSA to reach a value of 3 ng/ml but it did show a prolongation in prostate-specific antigen doubling time (PSADT)
- though not statistically significant, there was a trend observed in slowing the time to metastatic disease for patients who received sipuleucel-T against those who received placebo.
These findings have been presented Saturday, June 2, at 8 a.m. (CDT) at the 43rd Annual Meeting of the American Society of Clinical Oncologists (ASCO) in Chicago.
Manufactured by Dendreon Corporation, Provenge® (sipuleucel-T)’s safety and effectiveness in men with metastatic, androgen- independent prostate cancer (a different and more advanced patient population than those observed in this study) has recently been supported by an FDA advisory committee.
Once approved by the FDA, Provenge® (sipuleucel-T) would be the first FDA-approved treatment designed to train the body’s own immune system to fight cancer.
[FDA approval of Provenge® is expected very soon.]
Find more details from the full report.
[photo credit: forbes]
Provenge should be approved now.
FDA is a playing politics because of ther influences. The drug works and the patients should have a choice to live instead of death.
The FDA panel was flawed, 2 people with huge conflict of interest were on the panel.
Did the FDA run out of Doctors to let these two unethical people pass judgement on
Provenge? Dr. Hussain and Scher should be in Prison for killing people for their own personall gains(ties to other drug makers).
dear gloria,
please elaborate on your statement”[FDA approval of Provenge® is expected very soon.]“.
lpease give insight into your how you surmised a time frame of “very soon”
thanks
Give Provenge to patients if they want to try it. It can’t be worse than nothing or something that keeps them sick most of the time. We’re not talking about arthritis, but someting that is going to end in death, one way or another. Make Provenge available, track those whose chose to avail themselves of it, and compare their statistics to those who have not taken it, now or in the past. Put yourself in their place, because if it comes back to haunt you, it may well be through someone you love. Then the money won’t be important, treatment will be, because you can’t take money with you. My dad had prostate cancer, and he’s gone now.
actually,Provenge should have been approved already…only that FDA is delaying the approval and I do not know the real scoop on that). but phase 3 clinical trials have been successfully completed that’s why i said in this post that the FDA should approve it real soon.
Where in Europe can a patient get Provenge? In what clinic or hospital?
I am afraid that provenge is not in the market yet because it hasn’t been granted final approval. not even by the FDA in the U.S.
Though I understand that cancer patients tend to want all possible drugs, the FDA is too lenient, if anything, in approving new medications that offer miniscule gains. People say “what does it hurt to try it if you’re going to die anyway?” If this were something cheap and you were really paying out of your own pocket, I’d say all very well and good. But for, say, a 70 year old man who has maybe a 12 month life expectancy to force the rest of society to pay a huge bill just so he can live an extra month or two is not something I see as a great idea.
But don’t worry. Sooner or later it will be approved and join the host of other horrendously expense drugs that have very marginal benefits.