Regulators in Europe have followed their counterparts across the Atlantic and expanded approval for Johnson & Johnson's prostate cancer drug Zytiga.
The company's Janssen-Cilag unit announced that the European Commission has approved an extension to the licence of Zytiga (abiraterone acetate), which now includes its use in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who have failed on androgen deprivation therapy in whom chemotherapy is not yet indicated. Until now, the oral, once-daily drug, with prednisone and prednisolone, has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy.
J&J said that this latest approval means that eligible men "will potentially be able to benefit from treatment with Zytiga earlier in the treatment pathway". The decision follows recommendations from the Committee for Medical Products for Human Use of the European Medicines Agency that were based on data from a Phase III study, which was the first randomised study to demonstrate a radiographic progression-free survival benefit and a strong trend in overall survival.
Jane Griffiths, chairman of Janssen Europe, Middle-East, Africa, said the expanded approval by the European Commission "is hugely welcomed news" as it "marks another important step forward in the treatment of men with advanced castration-resistant prostate cancer. She added that "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".
Following a priority review, just over a month ago, the US Food and Drug Administration expanded approval of Zytiga to treat men with mCRPC prior to receiving chemotherapy.