Expanded indication for Janssen's Zytiga cleared in EU

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International said Friday that the European Commission has approved an extension to the license of the oral, once-daily prostate cancer drug Zytiga (abiraterone acetate).

The 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.

Until now, Zytiga with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen. This latest approval means that eligible men will potentially be able to benefit from treatment with Zytiga earlier in the treatment pathway.