Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based Astellas Pharma, Inc., announced today that Health Canada has approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).

This new approved use follows a Priority Review of the Supplementary New Drug Submission (SNDS) by Health Canada that was based on results of the Phase III PREVAIL trial. The trial was a randomized, placebo-controlled, multinational clinical trial that enrolled 1,717 chemotherapy- naïve patients with progressive metastatic prostate cancer who had failed ADT. The PREVAIL trial included thirteen Canadian trial sites including Kelowna, Vancouver, Victoria, Calgary, Edmonton, Winnipeg, London, Hamilton, Toronto, Ottawa, Montreal, Quebec City, and Halifax.

For more details, go to: http://www.cmsastellas.ca/uploads/pdf/Xtandi%20new%20indication%20final.pdf