The oral, once-daily androgen receptor inhibitor is indicated for treating metastatic castration-resistant prostate cancer patients, who were previously treated with docetaxel therapy, in the setting of medical or surgical castration.
In 31 August 2012, the US Food and Drug Administration approved Xtandi for the same indication and in 26 April 2013 the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted positive opinion on Xtandi.
The company submitted an application for marketing approval for the medication to the Ministry of Health, Labour and Welfare in Japan for prostate cancer.