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 investigational drug Abiraterone, designed for the treatment of men with advanced prostate cancer who have failed chemotherapy has not yet been approved by the FDA. Because of the extraordinarily positive results that were obtained on the phase III trials (which were stopped early because of these fantastic results) the pharmaceutical manufacturer of the drug [...]
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). The applications are for the approval of Abiraterone with prednisone for the treatment of metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane. [...]
In order to get FDA approval, drugs must first go through a clinical trial that demonstrates that they offer a better treatment result than the current standard of care. In some instances the better result can be a demonstration that the investigational drug provides an advantage which is only palliative (as Mitoxantrone does for advance [...]
Ortho Biotech & Development, a unit of Cougar Biotechnology, Inc. has unblinded their Phase 3 study of abiraterone acetate plus prednisone. In the trial the abiraterone was used for the treatment of men with metastatic advanced prostate cancer has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel. [...]