14 January 2019 - Astellas today announced that Health Canada approved an expanded indication for enzalutamide, an androgen receptor inhibitor for the treatment of patients with prostate cancer, following a priority review by Health Canada's Therapeutic Products Directorate.

With this designation, enzalutamide is now indicated to treat men with non-metastatic castration-resistant prostate cancer (nmCRPC), in addition to its existing indications for men with metastatic CRPC (mCRPC), making it a treatment option for both non-metastatic and metastatic CRPC patients.

The approval for the new indication was granted based on results from the Phase 3 PROSPER trial which demonstrated that the use of enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastasis or death compared to treatment with ADT alone in men with non-metastatic CRPC who were high-risk or experiencing rapidly rising PSA levels.

Read Astellas press release