The marketing authorisation for Zytiga (abiraterone acetate) has been approved by the European Commission after an accelerated regulatory review process by the EMA.
The androgen biosynthesis inhibitor has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed.
Professor Karim Fizazi, Department of Cancer Medicine, Institute Gustave Roussy, France, says its approval “gives new hope to men” suffering from the disease across Europe.
The fast-track review by the EMA followed a positive opinion by the CHMP in July.
Zytiga demonstrated in a pivotal Phase III study a 35.4% reduction in the risk of death and an improvement of almost four months in median overall survival.
“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,” added Professor Fizazi.
Prostate is the third most common cause of cancer deaths in Europe. An estimated 370,000 new cases were diagnosed across Europe, resulting in the deaths of nearly £90,000 men.