Sumitomo Pharma Canada announced that Health Canada has approved ORGOVYX (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available for prescription in Canada in Q1 2024.

"Roughly 1 in 8 Canadian men will develop prostate cancer in their lifetime, and the ability to suppress testosterone, primarily achieved through androgen deprivation therapy (ADT), is foundational in the treatment of the advanced stages of the disease," said Fred Saad, M.D., FRCS, Professor and Chairman of the Department of Surgery and Director of Genitourinary Oncology at the University of Montreal. "In the HERO study, ORGOVYX demonstrated rapid, sustained, and profound testosterone suppression when compared to leuprolide. ORGOVYX is the first approved ADT in Canada that can be administered orally, and once daily, offering a safe and effective option for advanced prostate cancer patients in the country."

"We're pleased that with Health Canada's approval of ORGOVYX, we are helping to expand upon treatment options for Canadian men living with advanced prostate cancer," said Lisa Mullett, General Manager of Sumitomo Pharma Canada, Inc. "We are committed to making ORGOVYX available to patients across Canada early in the new year."

The Health Canada approval was based on the results of the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study evaluating the safety and efficacy of ORGOVYX in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous ADT. In the Phase 3 study, ORGOVYX met the primary endpoint and demonstrated superiority in sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks compared to those receiving leuprolide acetate injections, the current standard of care. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea.

ORGOVYX was previously approved by the U.S. Food and Drug Administration on December 18, 2020 and granted marketing authorization by the European Commission for advanced hormone-sensitive prostate cancer on April 29, 2022.