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 [...]