The extended indication allows the use of Zytiga 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.
Janssen Europe, Middle-East, Africa, company group chairman Jane Griffiths said the decision by the European Commission 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," 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."
The decision was based on positive data from a randomised Phase III COU-AA-302 study.
Study demonstrated a radiographic progression-free survival (rPFS) benefit and a strong trend in overall survival (OS) in the patient population.
Zytiga, with prednisone and prednisolone, was previously approved to treat men with mCRPC whose disease has progressed during or after a docetaxel-based chemotherapy regimen.
The recent approval allows all the eligible men to benefit from treatment with Zytiga earlier in the treatment pathway, according to the company.