EU approves Zytiga for metastatic castration-resistant prostate cancer
First once-daily, oral treatment inhibits androgen production at all sources
After an accelerated regulatory review process by the European Medicines Agency (EMA) and following a positive CHMP opinion, the European Commission has approved the marketing authorisation for Janssen-Cilag International’s Zytiga (abiraterone acetate), a novel, once-daily, oral androgen biosynthesis inhibitor.
Abiraterone acetate is approved, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Abiraterone acetate is an androgen biosynthesis inhibitor that inhibits the CYP17 enzyme complex that is required for the production of androgens.
‘The European Commission approval of abiraterone acetate gives new hope to men who are suffering from this late stage of prostate cancer with very few treatment options left,’ said Professor Karim Fizazi, Department of Cancer Medicine, Institut Gustave Roussy, France, who was an investigator in the abiraterone acetate pivotal Phase 3 study. ‘The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain.’