Astellas Pharma Canada, Inc., 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 (TPD). 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. 

"Providing value to patients and finding solutions for unmet needs is at the core of all that we do," said Steve Sabus, General Manager, Astellas Pharma Canada, Inc. "Through this new indication, we are proud to deliver a new treatment option for patients who are diagnosed with non-metastatic castration-resistant prostate cancer."

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. Enzalutamide plus ADT demonstrated a statistically significant 71% reduction in relative risk of radiographic progression or death as compared to placebo plus ADT (HR 0.29, 95% CI 0.24-0.35, p<0.0001). Median metastasis-free survival (MFS) was 36.6 months (95% CI: 33.1, NR) in the enzalutamide arm versus 14.7 months (95% CI: 14.2, 15.0) in the placebo arm.¹

A total of 99 randomized Canadian patients were enrolled 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, Quebecand Nova Scotia. Data from the PROSPER study was presented at the 2018 Genitourinary Cancers Symposium (ASCO GU) in February and published 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."

Prostate cancer is the second most common cancer in men worldwide,² and the most common cancer to affect Canadian men³. The disease is the third most common cause of cancer deaths in Canadian males accounting for 10 per cent of all male cancer deaths.⁴  More than 21,300 men in Canada are estimated to have been diagnosed with prostate cancer in 2017.⁵

Non-metastatic CRPC is a disease state defined by rising levels of prostate-specific antigen despite castrate levels of testosterone and the absence of radiographic evidence of metastatic disease.^6, 7 Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.⁸

Enzalutamide was first approved by Health Canada in 2013 for the treatment of patients with metastatic CRPC who had previously received chemotherapy and was granted approval in 2015 for men with metastatic CRPC who had not undergone chemotherapy. It has been prescribed to more than 300,000 men worldwide since its initial approval in 2012.⁹

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