Provenge Approval

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Steve Jordan - 29 Mar 2007 22:21 GMT

Today, March 29, a (US) Food and Drug Administration committee voted
that Provenge is

1. Reasonably safe for the intended population, and
2. Has substantial efficacy.

Good news, for once.

Regards,

Steve J

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kh - 29 Mar 2007 23:49 GMT

> Today, March 29, a (US) Food and Drug Administration committee voted
> that Provenge is
[quoted text clipped - 7 lines]
>
> Steve J

Thanks Steve!!!!

I'ts not a cure but it gives guys more time, hope.

-kh hoping for more time.

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Richbro - 29 Mar 2007 23:54 GMT

> > Today, March 29, a (US) Food and Drug Administration committee voted
> > that Provenge is
[quoted text clipped - 13 lines]
>
> -kh hoping for more time.

Ditto on hoping for more time. Been declared hormone refractory here
and although taxotere lowered my PSA, bone mets have appeared and my
strength is losing ground. The hope alone is uplifting.

Rich

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Steve Jordan - 30 Mar 2007 00:00 GMT

I should have included this cautionary note:

The vote is by an advisory committee, not the full FDA. The latter is
scheduled to vote on the matter on May 15.

They usually vote in accordance with advisory committee findings, but
are not required to.

Nonetheless, a huge step in the right direction.

Regards,

Steve J

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Richbro - 30 Mar 2007 00:58 GMT

> I should have included this cautionary note:
>
> Steve J

Not to worry Steve, with all the ups and downs we all go though, if we
haven't learned to be cautionary by now , we will soon.

Rich

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Paul B - 30 Mar 2007 03:31 GMT

> I should have included this cautionary note:
>
[quoted text clipped - 9 lines]
>
> Steve J

I've been following this very closely, including today's meeting,
and I believe that the FDA very strongly wants this drug on the
market ASAP.

p.

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cognite tute - 30 Mar 2007 15:04 GMT

> Today, March 29, a (US) Food and Drug Administration committee voted
> that Provenge is
[quoted text clipped - 7 lines]
>
> Steve J

I glad that it's there.

I just hope I don't need it.

j.

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Jim - 30 Mar 2007 16:04 GMT

Steve

Provenge will probably be approved by the FDA.

I was in the clinical trial, and Provenge did nothing to help my
condition. It probably hurt in the long run.
My PSA pior to the trial was 550.58. After the trial it was 1399.7.
They cracked the code and found that I had gotten the vacine, not a
placebo. They have not been able to bring the PSA down. My latest
number was 3174 and I am now on Hospice.

I belive part of the problem is that I had to be off all chemo
treatments for 3 months prior to the trial. That gave the cancer a
chance to rejuvenate itself.

Even if it's eventually approved, I don't believe it will be a
commercial success due to it's delivery procedure. I had to go to a
lab where my white cells and plasma were extracted. Thast was an
unpleasant 2-3 hour procedure. The is added to the blood mix. Two
days later the mix was reinfused into me.
The side affects were very unpleasant. I was incapacitated for 2 days
following each treatment.
All that with the hope that it might add a couple of months to life

The Dendrion folks might be on the right track but Provenge is not the
final answer, in my opinion.

I don't want to sound too negative. I just wanted to share my
experience with the group. Provenge might help people with not very
aggressive cancer. Mine was not that. It blew through every thing
that was tried.

Jim

>Today, March 29, a (US) Food and Drug Administration committee voted
>that Provenge is
[quoted text clipped - 7 lines]
>
>Steve J

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Steve Kramer - 30 Mar 2007 17:02 GMT

> I don't want to sound too negative. I just wanted to share my
> experience with the group. Provenge might help people with not very
> aggressive cancer. Mine was not that. It blew through every thing
> that was tried.

I think that last point is an important one to make.... there seems to be
nothing that positively affects your particular cancer. One has to wonder
if a simpler remedy is warranted. Something like flooding it with
testosterone (Friedman?) or high scovel unit pepper.

However, your other point is also important. Provenge, where successful,
has, to my knowledge, added months, not years, to patients' quantity of
life.

Signature

PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32
Lupron 07/03 (1 mo) 8/03 (4 mo), 12/03, 4/04, 09/04, 01/05, 5/05, 10/05,
2/06, 6/06
PSA .07 .05 .06 .09 .08 .132 .145
Casodex added daily 07/06
PSA <0.04, <0.05
Non Illegitimi Carborundum

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J - 31 Mar 2007 01:18 GMT

> However, your other point is also important. Provenge, where successful,
> has, to my knowledge, added months, not years, to patients' quantity of
> life.

Same for all so called "new" chemos (in trials, many of which have carefully
selected patients) except Herceptin for a certain type of breast cancer (so a
select group of patients) and Glivec/Gleevec for GIST stromal tumors (so a
select group of patients).
J

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Leonard Evens - 31 Mar 2007 20:24 GMT

>> I don't want to sound too negative. I just wanted to share my
>> experience with the group. Provenge might help people with not very
[quoted text clipped - 9 lines]
> has, to my knowledge, added months, not years, to patients' quantity of
> life.

You have to be careful about that. The figure of so and so many months
added life expectancy is a statistical measure which helps researchers
compre different treatments. It doesn't tell you how long any one
person using it can expect to survive. If I understand correctly, for
example, the number surviving three years on Provenge was about 34
percent while the corresponding figure for another experimental
treatment was 11 percent. So this could have also been reported as a
three times increase in the number surviving at least three years, which
sounds more impressive. So when you see data like this remember that a
statistical measure which may be helpful to researchers is not
necessarily a good guide as to whether or not something might help you
significantly.

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Lud - 01 Apr 2007 16:24 GMT

...

> You have to be careful about that. The figure of so and so many months
> added life expectancy is a statistical measure which helps researchers
> compare different treatments. It doesn't tell you how long any one
> person using it can expect to survive.

As we all have a mix of different cancer cells, we all react
differently. Taxotere while it shows average survival time in months,
for some it doesn't work at all and for others it works for years. The
sad part of all these treatments is that the doctors have not been
able to identify which treatment works for what condition,
Women 's treatments are more advanced in targeting the cancer cells
even though they do not have a detection tool that is as sensitive as
the PSA.

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kh - 30 Mar 2007 18:44 GMT

...

Thanks. Your report helps me a lot.

-kh

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chasjac - 31 Mar 2007 00:37 GMT

>... My latest number was 3174 and I am now on Hospice ....

I'm truly sorry to hear that, Jim. Our prayers will be with you.

> ... Provenge is not the final answer, in my opinion ...

The idea behind Provenge is to find a way to stimulate the body's
immune system to attack the tumor cells; in this regard, it is
considred a vaccine, though not a preventative one. By getting the
drug approved, it helps the drug companies put more resources into
improving delivery, fine-tuning the treatment, and researching other
related possibilities.

The whole process is just so damned slow!!

--charlie

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