Once a clinical trial has been completed, especially when the trial is positive, researchers will “data mine” the published information. The published results provide additional opportunities to evaluate the data in different ways than the trial was originally designed. This new data can be very interesting and informative, however it also needs to be considered [...]
Before I get into the meat of today’s post about enzalutamide, I want to briefly make some personal comments about my absence from this blog. As I had mentioned I have been diagnosed with a fifth primary cancer, appendiceal cancer. It is a rare cancer, which required my having to remove my appendix, a piece [...]
On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic [...]
Expected and extraordinary news today on the new treatment front. Medivation and Astellas’ Xtandi (enzalutamide) was approved for use in men with castrate resistant prostate cancer. The new FDA approved label for Xtandi says that it is for the treatment of men with metastatic castration-resistant prostate cancer. This label is basically the same as for [...]