Over the last year or so we have seen a marked change in the treatment landscape for men with castrate resistant advanced prostate cancer. The FDA has approved sipuleucel-T (Provenge), cabazitaxel (Jevtana) and last week it also approved abiraterone (Zytiga). This changed landscape of multiple treatment options creates new problems, of course good problems. Prostate [...]
The FDA approval of Zytiga (abiraterone acetate) for men with advanced prostate cancer defines the men who qualify to receive the drug. To qualify you must have advanced prostate cancer and meet all of the three criteria below: 1- Men who are metastatic. 2- Men who failed hormone therapy also known as castrate resistant or [...]
The long awaited FDA approval of Zytiga (abiraterone acetate), a once-daily oral agent, for the treatment of castration-resistant, metastatic prostate cancer following docetaxel chemotherapy has happened! Malecare celebrates this approval as it celebrates the significant numbers of new drug approvals we have had over the last year and one half. The approval of Zytiga represents [...]
ABIRATERONE EXPANDED ACCESS Trial Site Contact Info – 3/25/11 for men with advanced prostate cancer (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 prostate cancer 3. no brain metastasis 4. failed chemo 5. no more than 2 different types of previous chemo […]
As we all anxiously wait for the FDA to finally make a determination about the pending application for approval of the investigational androgen biosynthesis inhibitor abiraterone acetate more data rolls in showing that supports the need to have a speedy approval. A new study published March 1, 2011, out of Italy adds support to the [...]
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 [...]
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%). [...]
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. [...]
