14 January 2013 - Janssen-Cilag International NV (Janssen) announced on Friday the approval by the European Commission (EC) of an extension to the license of the oral, once-daily medication ZYTIGA (abiraterone acetate).

This approved broader indication for ZYTIGA now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

Up till now, ZYTIGA with prednisone and prednisolone had only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

With this latest approval, now eligible men will potentially be able to benefit from treatment with ZYTIGA earlier in the treatment pathway.

The company said that the EC’s decision follows recommendations from the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency that were based on data from the Phase III COU-AA-302 study, which was the first randomised study to demonstrate a radiographic progression-free survival (rPFS) benefit and a strong trend in overall survival (OS) in this patient population.

Janssen-Cilag International NV is a division of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ), which develop products, services and healthcare solutions.