An Expanded Use of Xtandi in Canada

Health Canada has recently approved an expanded use for enzalutamide (Xtandi) so that it can now be prescribed to treat men with non-metastatic castration-resistant prostate cancer (nmCRPC).  This expanded label is in addition to the already existing indications for men with metastatic castrate resistant prostate cancer (mCRPC), making Xtandi a treatment option in Canada for men with both non-metastatic and metastatic castrate resistant prostate cancer.  

This new approval was granted based on results from the Phase 3 PROSPER trial which demonstrated that the use of Xtandi 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 a rapidly rising PSA level. 

A total of 99 randomized Canadian patients participated in the PROSPER trial, which had total participation of 1,401 patients. There were 14 trial sites in Canada, including locations in British Columbia, Alberta, Manitoba, Ontario, Quebec, and Nova Scotia. Data from the PROSPER study was presented at the 2018 Genitourinary Cancers Symposium (ASCO GU) in February and published in the New England Journal of Medicine in June.

"This approval is welcome news for physicians and patients alike," said Dr. Fred Saad, MD, FRCSC, Professor and Chief of Urology and Director of G-U Oncology at the University of Montreal Hospital Centres, and an investigator in the PROSPER trial.  "Reducing the risk of disease progression is an important treatment goal in patients with non-metastatic prostate cancer. With the PROSPER results, we can now use enzalutamide to treat men at an earlier stage in their disease."

 Xtandi was first approved by Health Canada in 2013 for the treatment of men with metastatic CRPC who had previously received chemotherapy and was granted approval in 2015 for men with metastatic CRPC who had not undergone chemotherapy.