Abiraterone - Application to FDA / EMA

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Jerry L.
Veteran Member

Date Joined Feb 2010
Total Posts : 3072
   Posted 12/30/2010 10:10 AM (GMT -6)   

Probably old news for most of you:

Applications for the approval of Abiraterone Acetate (Abiraterone) have been submitted to both the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA).



- Does anyone know of current/planned studies underway for Abiraterone? 




Nov. 2009 Dx at Age 44
Dec. 2009 DaVinci Robotic Surgery
Jan. 2010 T3b, Gleason 9
Feb. 2010 Adjuvant Radiation

PSA History:
Nov. 2009 4.30
Feb. 2010 <.05
May 2010 <.05
Aug. 2010 <.05
Nov. 2010 <.05

Veteran Member

Date Joined Dec 2008
Total Posts : 3149
   Posted 12/30/2010 1:13 PM (GMT -6)   
FYI- you can get this from Dr. Scholz and Dr. Lam in California right now, Johnson & Johnson made some kind of trial useage idea or exception (how??? don't know) was mentioned in Paact Newsletter just out recently, and is allowing them to dispense it right now. Sooooo, if someone is all that interested contact them and find out, others are using it right now.

In Phase III use right now from what I heard, so approval maybe soon-ish, maybe 1 year?
Dx-2002 total urinary blockage, bPsa 46.6 12/12 biopsies all loaded 75-95% vol.; Gleasons scores 7,8,9's (2-sets), gland size 35, ct and bone scans look clear- ADT3 5 months prior to radiations neutron/photon 2-machines, cont'd. ADT3, quit after 2 yrs. switched to DES 1-mg, off 1+ yr., controlled well, resumed, used intermittently, resumed useage

Jerry L.
Veteran Member

Date Joined Feb 2010
Total Posts : 3072
   Posted 12/31/2010 3:05 PM (GMT -6)   
"We are increasingly making prostate cancer a chronic disease that the patient can live with by giving drug after drug," he said. "I think they (new drugs) will probably be given in series rather than added together."

Abiraterone was tested in patients who had metastatic castration-resistant prostate cancer, meaning their tumors were still growing despite receiving Sanofi's older chemotherapy drug Taxotere and hormone therapy designed to reduce testosterone.

In future, researchers plan to test abiraterone in men diagnosed with prostate cancer at an earlier stage of disease.


I'm just curious what stages, etc... will Abiraterone be tested...



Regular Member

Date Joined Mar 2010
Total Posts : 495
   Posted 12/31/2010 3:12 PM (GMT -6)   
Go to clinicaltrials.gov and enter abiraterone to see the trials. There are many. One is even before treatment with surgery. I think someone who posted here had participated in that one.
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