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 [...]
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 [...]
On September 27th Dendreon announced that it has enrolled and started its first patient with metastatic advanced prostate cancer that is castrate resistanr in a European Union based clinical trial of Provenge. Finally, men in the EU can hope that in the near future that Provenge could become available to them. The trial is hoped [...]
Recently, it was announced that there was a submission by Astellas and Medivation to the European Regulatory Agency for Enzalutamide (MDV-3100) for the treatment of men with advanced prostate cancer post-chemotherapy The basis of the submission was the pivotal phase 3 AFFIRM study. The Marketing Authorization Application (MAA) that was made to the European Medicines [...]
