Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has received European Commission, or EC, approval for an extension to the license of the oral, once-daily medication ZYTIGA.
The approved broader indication for ZYTIGA 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.
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. This was the first randomized study to demonstrate a radiographic progression-free survival (rPFS) benefit and a strong trend in overall survival (OS) in this patient population.
Study COU-AA-302 is a Phase III, international, randomised, double-blind, placebo controlled study which evaluated ZYTIGA plus prednisone/prednisolone compared to placebo plus prednisone/prednisolone in 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received prior chemotherapy. The co-primary endpoints of the study were radiographic progression-free survival (rPFS) and overall survival (OS).
Jane Griffiths, company group chairman, Janssen Europe, Middle-East, Africa, commented, "This decision by the European Commission is hugely welcomed news. It marks another 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. 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."