Some mornings we just wake up to great news and today is one of those mornings. The Food and Drug Administration (FDA) has just announced that they have approved Zytiga (abiraterone acetate) for use prior to chemotherapy. - This FDA announcement is an expansion of their prior approved (April 2011) for the use of Zytiga [...]
We all know that abiraterone acetate (Zytiga) plus prednisone provides a survival advantage for men with castrate resistant advanced prostate cancer (mCRPC) who have had prior treatment with a taxane based chemotherapy. New information has shown that abiraterone acetate offers a somewhat longer overall survival benefit than the data originally presented when the trial halted [...]
According to researchers at Weill Cornell Medical College in the Sept. 15 issue of the journal Cancer Research, taxne-based chemotherapy drugs are not well understood as they may be more powerful than many have believed. Generally, it is believed that taxane chemotherapy (paclitaxel, docetaxel and cabazitaxel) just stop a cancer cell from dividing -- but [...]
The U.S. Food and Drug Administration today, August 31, 2012 approved Xtandi® (MDV3100) (enzalutamide) capsules to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with chemotherapy, Xtandi was reviewed under the FDA’s priority review [...]
On Wednesday, Johnson & Johnson said that the FDA will conduct a fast review of Zytiga as a treatment for men with advanced prostate cancer who have not received chemotherapy. The Food and Drug Administration has agreed to conduct a six-month review of Zytiga which should be completed in mid-December, 2012. According to representatives from [...]
My very dear friend and advocate supreme, Jan Manarite, from PCRI has sent me an update on MDV3100 (enzalutamide). As usual her information is important, so I thought I would pass it on today. • She points out that once the FDA approves MDV3100 (I am going to work on the assumption that it will [...]
The National Health Service cost regulators for England and Wales have recommended the use of Zytiga in the treatment of men with castrate resistant advanced prostate cancer. The National Institute for Health and Clinical Excellence (NICE) has published a final guidance endorsing Zytiga as an NHS treatment option for men with advanced, metastatic, castration resistant [...]
Medivation and Astellas Announce Initiation of Expanded Access Program for Enzalutamide (MDV3100) in the United States for men with metastatic prostate cancer previously treated with chemotherapy. Medivation, Inc. and Astellas Pharma Inc. today announced that they have come to an agreement with the U.S. Food and Drug Administration (FDA) which will allow them to proceed [...]
In one of those situations when actual clinical practice precedes the normal drug development process a recent announcement from Janssen Research & Development, LLC (Johnson & Johnson) informs that they have un-blinded their Phase 3 study, COU-AA-302, which clearly demonstrates that Zytiga (abiraterone acetate), when taken with prednisone, is effective in treating both mildly symptomatic [...]
We are about to finally get a more formal presentation of the great news we have all been waiting to hear. Medivation Inc. and Astellas Pharma Inc. announced that data from their Phase 3 AFFIRM trial, evaluating MDV3100 in men with advanced prostate cancer, will be highlighted in a late-breaking oral presentation at the upcoming [...]
