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 receptor inhibitor, some men have likened it to a supercharged Casodex. It blocks androgens from being able to be used by the prostate cancer cells.
CHMP is the committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines. The committee is responsible for preparing The European Medicines Agency’s opinions on all questions concerning human medicines. The Agency is the equivalent to the FDA in the United States. No medicine can be marketed without the Agency approval. Its authority covers all European Union (EU) Member States, as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.
The recommendation is based on the positive results from the phase III study Affirm showed that Xtandi delivered a statistically significant improvement in overall survival rates compared to placebo, as well as being generally well-tolerated.
This is good news for our European brothers.
Joel T Nowak, M.A., M.S.W.