XTANDI® (enzalutamide) Receives Health Canada Approval as the First and Only Treatment for High-Risk Patients with Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

MARKHAM, ON, January 30, 2024 – Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting. With this approval, XTANDI becomes the first and only androgen receptor pathway inhibitor (ARPI) approved for use with or without a GnRH analog therapy in patients with nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR).[i] 

Health Canada granted a priority review of XTANDI in nmCSPC, which was further expedited as a result of XTANDI’s inclusion in Project Orbis, an initiative of regulatory bodies, including Health Canada, with an aim to give patients faster access to promising cancer treatments around the world. 

Prostate cancer develops when abnormal cells form and grow in the prostate gland.[ii] Prostate cancer is considered nmCSPC if there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.[iii] Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.[iv] About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of their metastatic prostate cancer.[v]

“BCR is usually the first manifestation of recurrence following treatment for prostate cancer and some of these patients are at high risk of early metastases and eventual death from prostate cancer,” said Dr. Fred Saad, Professor and Chairman, Department of Surgery, University of Montreal. “I welcome the approval of XTANDI as a promising earlier treatment option for eligible patients. This marks a significant step forward in addressing unmet needs for prostate cancer treatment.”

As the most common cancer among Canadian men, prostate cancer accounts for an average of 71 new diagnosis every day.[vi] It is estimated that about 1 in 8 Canadian men will develop prostate cancer during their lifetime and 1 in 30 will die from it.[vii] Approximately 98% of cases occur in men above the age of 50.[viii]  

This indication is based on the results of the EMBARK trial, the first Phase 3 registrational study to demonstrate a statistically significant improvement in metastasis-free survival (MFS) using the combination of XTANDI plus ADT and XTANDI as monotherapy in men with nmCSPC with high-risk BCR.[ix] Canadian patients contributed approximately 10% of enrollment in the EMBARK trial.  

“Astellas puts patients at the centre of our work. For more than 12 years, we have been advancing innovative treatments in hard-to-treat cancers with few or no current therapeutic options,” said Frank Stramaglia, General Manager, Astellas Pharma Canada, Inc. “The latest indication for XTANDI is a clear demonstration of our ongoing commitment to patients and the physicians who treat them. With our recent acquisition of Propella Therapeutics, Inc., we strive to achieve even more in the investigation of targeted prostate cancer treatments for patients of the future.”

About XTANDI (enzalutamide)

XTANDI is an - Androgen Receptor (AR) inhibitor that overcomes resistance to conventional antiandrogens by inhibiting AR signalling at multiple steps in the pathway.[x] Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.[xi] XTANDI has been prescribed to more than one million patients globally since 2012 including 33,200 to patients in Canada.[xii]

XTANDI is a standard of care that has received regulatory approvals in more than 90 countries, including the United States, the European Union and Japan. In Canada, XTANDI is now approved for use in men in four prostate cancer disease states across five indications: 

  • Metastatic castration-resistant prostate cancer (mCRPC): chemotherapy naïve and post-docetaxel
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Metastatic castration-sensitive prostate cancer (mCSPC)
  • Non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). 



The approval is based on results from the Phase 3 EMBARK trial of XTANDI (enzalutamide) plus ADT (n=355), placebo plus ADT (n=358), and XTANDI as monotherapy (n=355) in men with nmCSPC with high-risk BCR. The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmCSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a prostate-specific antigen (PSA) doubling time (PSA-DT) ≤ 9 months. High-risk BCR patients with a PSA-DT of ≤ 9 months have a higher risk of metastases and death. The study showed that treatment with XTANDI plus ADT reduced the risk of metastasis or death by 58% versus placebo plus ADT (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; p<.0001) as assessed by the primary endpoint of metastasis-free survival (MFS). 

Detailed results from the primary analysis of EMBARK were presented as a plenary session during the 2023 American Urological Association (AUA) Annual Meeting and published in the New England Journal of Medicine.

An analysis of health-related quality of life (HRQoL) in patients from the EMBARK trial were recently presented at the European Society of Medical Oncology (ESMO) Congress 2023 and subsequently published in NEJM Evidence.

About Astellas Canada

Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical company conducting business in more than 70 countries around the world.

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Learn more: https://www.astellas.com/ca/ 

For more information:

Dara Willis
Director, Product & Corporate Communications
Astellas Pharma Canada, Inc. 
Mobile: 647-207-3033
[email protected]

[i] Astellas. NOC Letter (details to come)

[ii] American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2021). http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Accessed December 2023.

[iii] American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2021). http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Accessed December 2023.

[iv] Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174- 82. doi: 10.1038/ncpuro0145. PMID: 16474760.

[v] Antonarakis, Emmanuel S et al. “The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up.” BJU international vol. 109,1 (2012): 32-9. doi:10.1111/j.1464-410X.2011.10422 

[vi] Canadian Cancer Society. Prostate Cancer Statistics. https://cancer.ca/en/cancer-information/cancer-types/prostate/statistics. Accessed December 2023.

[vii] Canadian Cancer Society. Chances (probability) of developing or dying from prostate cancer. https://cancer.ca/en/cancer-information/cancer-types/prostate/statistics. Accessed December 2023.

[viii] Canadian Cancer Statistics Advisory Committee. Canadian Cancer Statistics 2023. 2023_pdf_en.pdf (cancer.ca).

[ix] XTANDI Product Monograph. January 5, 2024.

[x] XTANDI Product Monograph. January 5, 2024.

[xi] XTANDI Product Monograph. January 5, 2024.

[xii] Astellas. Data on File. XTANDI patient. Accessed December 2023.