An announcement from Market Watch claims that Cougar Biotechnology has come to an agreement with the US Food & Drug Administration (FDA) to conduct an additional Phase III trial of abiraterone acetate in prostate cancer.
The currently ongoing and much in demand Phase III trial of abiraterone acetate was designed for prostate cancer survivors who had already failed at least one docetaxel-containing drug regimen (chemotherapy). Many survivors who are not as progressed have been frustrated because this trial was restricted solely to late stage survivors.
This new trial will be enrolling approximately 1,000 chemotherapy-naïve and hormone resistant (castration resistant) survivors. Many of us feel that abiraterone might be able to provide a positive profile for earlier progressed disease than the current trial allows. If this new trial provides a positive result it would offer the potential for FDA approval of abiraterone acetate for use significantly earlier in the course of the disease.
The trial will be a randomized, double-blind, placebo-controlled trial (CB7630) plus prednisone in survivors with metastatic, castration-resistant prostate cancer who have not yet received treatment with chemotherapy. The trial will be randomized (1:1) so that subjects will receive abiraterone acetate plus prednisone or placebo plus prednisone.
Cougar plans on having approximately 150 trial sites in North America, Europe and Australia. Cougar and the FDA have agreed upon multi-primary endpoints of this new trial. The end points will be progression-free survival and overall survival.
The other good news is that according to the announcement, Cougar anticipates starting enrollment survivors into this trial before the end of March 2009.
Joel T Nowak MA, MSW
2/3/2010
What is the current status of FDA approval of Abiraterone?
Jan,
All of the trials are either in processor in process and still recruiting subjects. So, the FDA has not received any data to date. My guess is that we are still a few year from approval, assuming that the numbers warrant approval. – Joel
Hi Guys,
I work at the ICR in London, UK. They made Abiraterone in 1999 and sold it to Cougar!! It was amazing in 2005 when ICR and the Royal Marsden did the first trials in patients and I remember Gert Attard (the lead author on the first study) being so excited a few weeks into the trial!! As far as I know the Phase III trials are going really well and pending these you guys should get FDA approval in 2011 as planned. Hopefully NICE in the UK will also approve the drug for use on the NHS, although it is already pretty standard treatment for those men who have CRPC.
As Joel has rightly pointed out, Abiraterone is not a cure. Many of the guys who started on the Abiraterone trial in 2005 and who responded well have started to relapse now. But, I guess that’s a few years that they would not have had. However, the important thing now is that we get to grips with what causes the relapses. This is how cancer treatment will evolve in the future. They already have some good ideas about this and some of those patients have been moved onto new trials.
I think the future looks promising!!
Chris