Current Update on the Abiraterone Expanded Access Trial

The latest from Jan Manarite of PCRI about the getting early access to Abiraterone for men with advanced prostate cancer and who have failed chemotherapy: Abiraterone expanded Access Trial Site Contact Info – 2/7/11 (800) 457-6399 M-F, 9am –5pm, EST TRIAL link: http://www.clinicaltrials.gov/ct2/show/NCT01217697?term=abiraterone&recr=Open&rank=6 Basic Criteria: 1. testosterone less than 50 2. metastatic 3. no brain [...]

Abiraterone Acetate Now Available in the North East, United States

From Jan Manarite: To all, Many of you who have advanced prostate cancer may have been watching a drug in development called Abiraterone Acetate. It is not yet FDA approved, but trials look very good, and side effects appear to be very few. Most common side effects are fluid retention (30.5%), and low potassium (17.1%). [...]

NDA Has Finally Submitted for FDA Approval of Abiraterone, A Very Promising Treatment for men with Metastatic Prostate Cancer

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. [...]

Abiraterone, A Compassionate Use Program & Trial for Men with Advanced Prostate Cancer After Chemotherapy Failure

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 [...]

An Update on the FDA & EMA Submissions for Abiraterone for the Treatment of Metastatic Advanced Prostate Cancer

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. [...]

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