Regulatory Affairs

Janssen-Cilag wins extended license to Zytiga in Europe

PBR Staff Writer Published 14 January 2013

The European Commission (EC) has approved broader indication of Janssen-Cilag International's oral, once-daily medication Zytiga (abiraterone acetate).

Licence extension includes the use of Zytiga as a combination therapy along with prednisone or prednisolone to treat metastatic castration-resistant prostate cancer (mCRPC), in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

Janssen Europe, Middle-East, Africa, company group chairman Jane Griffiths said the European Commission's decision is an important step forward in the treatment of men with advanced castration-resistant prostate cancer.

"Treating men with ZYTIGA before they undergo chemotherapy has been shown to improve outcomes in many patients, both in terms of extending survival and in bettering quality of life," Griffiths added.

"The fact that ZYTIGA's licence has now been extended to include this indication will help fill a critical medical need and, we hope, serve to significantly improve the lives of many men across Europe suffering from this disease."

Zytiga with prednisone and prednisolone was previously approved for the treatment of men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

The approval was based on data from the Phase III COU-AA-302 study that demonstrated a radiographic progression-free survival benefit and a strong trend in overall survival in the patient population.