Prostate cancer drug so effective trial stopped (Johnson & Johnson's Zytiga)

Hello folks.

This report just out might give hope to some of us... Thought i'd share it just in case it does.

My best thoughts to you all..

Here is a bit of it.....

A new drug for advanced prostate cancer patients has proved so effective that researchers stopped the clinical trial early to give all patients a chance to receive the life-extending medication, according to a UCSF-led study released Saturday.

The hormone treatment, Johnson & Johnson's Zytiga, when added to a standard steroid therapy doubled the time it takes for the disease to progress in patients treated with the standard therapy alone, said the lead researcher, Dr. Charles Ryan, associate professor of clinical medicine at the UCSF Helen Diller Family Comprehensive Cancer Center.

Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/06/02/MNI11ORI84.DTL#ixzz1weC6ubYZ

A very promising report. I find it interesting that they would cut the trial short.

Hopefully this will help a bunch of guys out there.

Brothers

I've been on Abiraterone + Prednisone since 22 March.

I am also on Lupron (Eligard) every 3 months and Zometa (for bone health) monthly

So far the Abiraterone + Prednisone has been successful as you can see from my signature.

Bud

Don't count on the drug being approved for earlier indications though, since the FDA hates failed clinical trials. The overall survival advantage wasn't statistically significant, which means that the drug doesn't necessarily improve survival. If the article were more balanced it would have mentioned this. But then it would have had to talk about statistics and clinical trials, which most people probably don't want to read about.

Jerry

Side Effects, I'm dealing with the general HT type side effects and also the Prednisone side effects.

What Zytiga does in the simplest terms is to block virtually ALL testosterone. So;
Hot flashes - was getting prior to Zytiga but when do get seem to be more severe. I've told myself the hot flashes are good as means the stuff is working
Night Sweats - not 100 % sure if from Zytiga - but they have gotten much worse since I went on the treatment. Sleep with a overhead fan on - helps a lot.
Spend considerably more time picking out my outfit for the day.
New found enjoyment of soap operas.
Headache - oh wait that was actually a hangover after I celebrated my PSA drop to 66.2.
Continued ED - well I've been on HT's since last Aug. - BUT - MUSE works for me!
Increased occurrences of flirting with wife. - Hmm a MUSE side effect?

To Prednisone I attribute
Difficulty with sleep
Occasional ravenous hunger. NOT skipping meals helps with this, but does not eliminate.
Some edgeless at times. - Actually seems if I miss (I take 2x a day) - seems to occur about 24 hours later, even though I had taken within that 24 hour period. - Coincidence ? Unrelated? Dunno but have enlisted the wife to make sure I do not skip the Pred.

My oncologist is very upbeat on Zytiga and wants to use that before chemo (as he is doing with me), this is a recent development of about 4 months ago. Prior to that it was Chemo first - fail - only than Zytiga.

I understand Zytiga HAS been FDA approved, but that approval was for use after failing chemo. What is being worked on now is approval before chemo. I could be wrong on that.

Bud

I have been on Zytiga, Prednisone, and Lupron for 6 months now. This is the end of the active treatment phase of the clinical trial I am participating in. I will concur with Raddad's observations on side effects. Mine have been very similar. The only difference is that instead of shoe shopping urges, I find myself taking longer and longer picking out my hospital gown. ;) I would say the SE have been very tolerable and it is difficult to attribute any of them to Zytiga.

Obviously I am hoping this treatment provides me with a better outcome than existing treatments and that the early use of the newer class of HT drugs can bring real hope to us all. As you can see from my statistics, 1 month of treatment brought my PSA down to 1.6 from 48, so I feel good about the results.

-Winter

Some stock analysts are criticizing J&J for unbinding the study early. They were not sure about the adequacy of the statistics on survival.

Some analyst also mentioned that Zytiga may go generic in 2014. (Based on the patent date.)

Post Edited (robertcool) : 6/4/2012 7:26:34 AM (GMT-6)

Bud and Winter, I wish you both continued success.  Bud, it is good to see that PSA going down!  I haven't heard much about MUSE.  Can you tell me more?  Ron got a booklet but we haven't done much in regards to the ED.  It sounds encouraging!

"Continued ED - well I've been on HT's since last Aug. - BUT - MUSE works for me!
Increased occurrences of flirting with wife. - Hmm a MUSE side effect?"

 

New Zytiga application:

Johnson & Johnson files for new Zytiga approval
Posted on June 15, 2012



NEW BRUNSWICK, N.J. (AP) — Johnson & Johnson said Friday it has asked U.S. and European Union regulators to grant broader marketing approval for its cancer pill Zytiga.

Zytiga was approved in 2011 for the treatment of advanced prostate cancer in men who have received chemotherapy and who have not been helped by other hormone-blocking drugs. On Friday Johnson & Johnson said it asked regulators to approve Zytiga for men who have not been helped by hormone treatment but have not yet been treated with chemotherapy, and who have few or no symptoms from their cancer.

Earlier this month Johnson & Johnson reported strong results from a clinical trial involving men who had received hormone treatment and not chemotherapy. The company said Zytiga doubled the amount of time patients lived without their cancer getting worse.

Johnson & Johnson shares rose 29 cents to $65.74 in morning trading.