It has been announced that the application for the FDA approval of abiraterone with prednisone has been submitted by Centocor Ortho Biotech Inc. As I have discussed in prior posts, abiraterone is an extraordinarily promising investigational drug designed to treat metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane.
The filing of the application follows completion of a phase III, randomized, double-blind, placebo-controlled clinical study, which evaluated overall survival and tolerability in men with metastatic advanced prostate cancer treated with abiraterone plus prednisone compared with treatment with placebo plus prednisone. The data from this multi-center study, which included 1,195 men from 13 countries, has already been presented at the 2010 European Society for Medical Oncology annual congress in Milan, Italy.
The data was so positive the trial was halted and unblinded prior to the projected completion goals being met. I am hopeful that abiraterone will be approved in the middle of 2011.
Joel T Nowak, M.A., M.S.W.
Dear Mr Nowak,
Prostate cancer was just diagnosed with my father. I did some reading, and I am happy to read about your fantastic work.
Congratulations.
Is it possible, anyhow, to get Abiraterone Acetate?
As from the results we can see, it works.
Thank you again for your efforts, mankind can really be proud of you!
Sincerely,
György Kálmán
My father in law has metastatic prostate ca if I can get some info regarding this new drug..
Gyorgy, Abirterone is not yet approved in the United States, or in any country. It is possible for a limited number of men to get it prior to approval, read the post “Abiraterone, A Compassionate Use Program & Trial for Men with Advanced Prostate Cancer After Chemotherapy Failure” in this blog. I am hopeful that in the US it will be approved in mid-2011, but it is only a hope. I am not familiar with any current attempts for approval outside the United States. – Joel
Search the blog for abiraterone and you will find many posts that talk about it. – Joel
Dear Dr,
My father already had prostate cancer for 2 yrs, he already tried chemo, but still cannot stop his PSA index. Now, no more mediciation is given to him, his PSA is kept increasing to 400. I just heard that the new drug – Abiraterone start recruiting patients for the clinical trial, but I don’t know the criteria. Do you think this new srug is work for him as his condition is not quite good at this moment.
Really looking forward to your reply!
Best Regards,
Joanna (HK)
Joanna,
I can not tell you if Abiraterone is the best option for your dad, you will need to speak with his doctors. I am concerned that he is not receiving any treatment, I don’t know of any situation where that is the best approach. Go back to the doctor, maybe even get a new doctor.
Joel
I have had Prostate Cancer since 1995 and have been through surgery, radiation, and hormonal therapy; but have not had chemotherapy. I have recently failed hormonal therapy with Cassodex and would like to try Abiraterone. What can I do to qualify for early access or a clinical trial? When does it appear that Abiraterone will be approved by the FDA for general usage?
On March 26th I posted the update of new sites offering Abiraterone. You can see the post, “The Latest on the Expanded Access Trial for Abiraterone- New Locations” at:http://advancedprostatecancer.net/?p=2470
My husband has metastatic prostate cancer. He has had radical prostatectomy/orchiectomy as well as radiation and chemotherapy(taxanes) His oncologist says that Abiraterone is the next step. Do you know when this medication will be on the market and available to patients who are not part of a clinical trial? At this time he is receiving no treatment. His oncologist says to wait for Abiraterone.
Pat,
We can not say for sure, but many of us hope and believe that the approval will come some time in the summer. Although the evidence seems overwhelming, there is never a guardsmen of an approval.
I do suggest that you join our Advanced Prostate Cancer on-line group where over 600 of us teach and support each other to battle this disease.
You can join by going to: http://health.groups.yahoo.com/group/advancedprostatecancer/join
Joel
In response to Pat Thralls: you dont say anything about hormone blockade.
sorry Pat, missed orchiectomy. go to clinicaltrials.gov and look for NCT 01217697—early access for arbiterone. Many sites than previously known.