It was announced today that after observing significant benefits in overall survival (OS) and radiographic progression free survival (PFS) ,the two co-primary endpoints of the the Xtandi pre-chemotherapy trial, the Independent Data Monitoring Committee (IDMC) for The Phase 3 PREVAIL trial of enzalutamide in metastatic prostate cancer recommends that "the study be stopped and patients [...]
Today’s post will be a little admonishment of you, my loyal readers. So, please be open-minded and think about what I have to say to you. A number of months ago I mentioned the new prostate cancer research-funding project we have embarked upon, Start A Cure (www.StartACure.com). For those of you who might have missed [...]
Researchers at Johns Hopkins has concluded that metastasis-free survival appeared to independently predictor of overall survival (OS) in men with recurrent prostate cancer who underwent androgen deprivation therapy (ADT) after developing metastases. Men with biochemically recurrent prostate cancer (PSA only) tend to survive for long periods so the FDA gold standard for clinical trial endpoint [...]
The great news for for our brothers in Europe is that Xtandi (Enzalutamide) has been approved for use in the European Union (EU) for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after chemotherapy (docetaxel). Following the regulatory review process by the European Medicines Agency (EMA) and a [...]
Some good news for men who are living in Japan and dealing with advanced prostate cancer. It was announced that Astellas and Medivation have submitted an application for marketing approval of Enzalutamide (Xtandi) in Japan. Their application is based on results obtained from the global Phase 3 trial (the AFFIRM trial)* and a Phase 1-2 [...]
There was a lot of interesting and important presentations at the recent American Urological Association meeting, however the one item that will have the most impact on men with advanced prostate cancer is the new guidelines that were proposed for the treatment of men with castrate resistant prostate cancer. The guidelines were organized by creating [...]
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted approval of Xtandi in the treatment of men with castrate resistant prostate cancer that has progressed after the use of chemotherapy. It has already been approved for use in the United States. Xtandi (aka Enzalutamide and MDV3100) is a strong androgen [...]
There was a recent interview in the Pharma Strategy Blog with Dr. Bertrand Tombal , an academic urologist in Belgium. Dr. Tomal discussed several of the new advances in the treatment od advanced prostate cancer with an emphasis on the potential future of Enzalutamide (Xtandi). Like bicalutamide (Casodex), Xtandi works by blocking (inhibiting) testosterone from [...]
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 [...]
The summer is coming to a close and I am back, ready to again take on the world. I had the fantastic opportunity of spending almost two weeks in Alaska, a land that is so different from the lower 48. I have to say that I have a new found respect for those individuals who [...]
