Sumitomo Pharma’s ORGOVYX Receives Health Canada Approval for Advanced Prostate Cancer Treatment

MISSISSAUGA, Ontario, Oct. 23, 202— In a significant development in the field of advanced prostate cancer treatment, Sumitomo Pharma Canada, Inc. has announced that Health Canada has granted approval for ORGOVYX® (relugolix). ORGOVYX, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, is the first and only medication of its kind to be approved for advanced prostate cancer in Canada. The approval comes after a rigorous evaluation of the Phase 3 HERO study, which demonstrated the drug’s efficacy and safety in men with advanced prostate cancer. ORGOVYX is expected to become available for prescription in Canada in the first quarter of 2024.

Prostate cancer affects approximately 1 in 8 Canadian men during their lifetimes, making it a significant health concern in the country. Testosterone suppression, primarily achieved through androgen deprivation therapy (ADT), is a fundamental aspect of advanced prostate cancer treatment. In the HERO study, ORGOVYX proved to be highly effective, offering rapid, sustained, and profound testosterone suppression when compared to leuprolide, a current standard of care. ORGOVYX stands out as the first orally administered ADT in Canada, providing a convenient and safe treatment option for patients.

Fred Saad, M.D., FRCS, Professor and Chairman of the Department of Surgery and Director of Genitourinary Oncology at the University of Montreal, commented on the significance of this approval, noting that ORGOVYX’s effectiveness in testosterone suppression sets it apart as a critical advancement in the treatment of advanced prostate cancer in Canada.

Lisa Mullett, General Manager of Sumitomo Pharma Canada, Inc., expressed the company’s commitment to making ORGOVYX accessible to patients across Canada in the early months of the coming year, expanding treatment options for those living with advanced prostate cancer.

The Health Canada approval was based on the results of the Phase 3 HERO study, a comprehensive clinical trial involving over 1,000 men with androgen-sensitive advanced prostate cancer. These men required at least one year of continuous ADT. The study found that ORGOVYX achieved its primary objective and demonstrated its superiority in maintaining testosterone suppression to castrate levels (less than 50 ng/dL) for 48 weeks compared to patients receiving leuprolide acetate injections. Notably, the most common adverse events reported by ORGOVYX patients included hot flushes, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea.

This approval by Health Canada follows ORGOVYX’s previous authorization by the U.S. Food and Drug Administration on December 18, 2020, and its marketing authorization by the European Commission for the treatment of advanced hormone-sensitive prostate cancer on April 29, 2022.

Prostate cancer is a significant health concern in Canada, with an estimated 24,700 men expected to be diagnosed in 2023. Advanced prostate cancer includes cases where the disease has spread or returned after initial treatment. The front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, referred to as castrate levels. ORGOVYX’s approval marks a significant advancement in providing a more convenient and effective treatment option for men with advanced prostate cancer in Canada.

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