XTANDI is the first and only androgen receptor pathway inhibitor (ARPI) indicated and reimbursed in Ontario for use in patients with nmCSPC with biochemical recurrence at high risk for metastasis

MARKHAM, ON , June 26, 2025 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that XTANDI^® (enzalutamide) is now funded by the Ontario Drug Benefit Program under the Exceptional Access Program for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence (BCR) at high risk of metastasis (high-risk BCR).ⁱ This decision means XTANDI is now publicly reimbursed in Ontario for all of its approved prostate cancer indications.

Health Canada granted Astellas market authorization for XTANDI in nmCSPC in January 2024. This approval was 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 in some countries around the world. The swift decision to reimburse XTANDI in Ontario is an important milestone towards making this important therapy available to Ontarians.

"The public reimbursement of XTANDI in Ontario is important because it expands access to a vital treatment for prostate cancer patients who are at high risk of metastasis," said Tony Finelli, MD, FRCSC, Professor of Surgery and Chair of Urology, University of Toronto, Urologic Oncologist, University Health Network (UHN). "Reducing the barriers to accessing XTANDI allows us as physicians to offer even more comprehensive care to those navigating the challenges of living with prostate cancer."

"We applaud Ontario's decision to publicly reimburse XTANDI for the treatment of nmCSPC patients with high-risk BCR," said Sandra Heller, General Manager, Astellas Pharma Canada. "At Astellas, we remain dedicated to ensuring that patients have access to the therapies they require for better health outcomes, and we are honoured to support men facing this difficult journey."

Reimbursement Criteria
Specific reimbursement criteria must be met for public coverage of XTANDI. Complete information can be found by consulting the Ontario Drug Benefit Program under the Exceptional Access Program for details.

About nmCSPC
Prostate cancer develops when abnormal cells form and grow in the prostate gland.ⁱⁱ nmCSPC describes the early stage of prostate cancer wherein the disease remains localized and 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 per cent 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

As the most common cancer among Canadian men, prostate cancer accounts for an average of 76 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 per cent of cases occur in men above the age of 50.^viii

About XTANDI (enzalutamide)
XTANDI is an androgen receptor (AR) inhibitor that overcomes resistance to conventional antiandrogens by inhibiting AR signaling at multiple steps in the pathway.^ix XTANDI is approved for use in men in four prostate cancer disease states across five indications:

• The treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of metastasis (high-risk BCR).
• The treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
• The treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
• The treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients: chemotherapy-naïve and post-docetaxel

Please consult the Product Monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The product monograph is also available by calling Astellas Medical Information at 1-888-338-1824.

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.

About XTANDI Patient Assistance Program
Astellas is committed to supporting patients prescribed XTANDI through the XTANDI Patient Assistance Program by offering coverage navigation, financial assistance, patient and caregiver education as well as specialty pharmacy dispensing. Patients with a valid prescription can be enrolled by calling 1-855-982-6348.

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

Astellas is committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at https://www.astellas.com/ca/

SOURCE Astellas Pharma Canada, Inc.