Canadian Authorities Approve Relugolix for Advanced Prostate Cancer

"...[Relugolix] is the first approved ADT in Canada that can be administered orally, and once daily, offering a safe and effective option for patients [with advanced prostate cancer] in the country," according to Fred Saad, MD, FRCS.

Relugolix (Orgovyx) has received approval from Health Canada as a treatment for patients with advanced prostate cancer, according to a press release from Sumitomo Pharma Canada, Inc.¹

“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,” Fred Saad, MD, FRCS, professor and chairman of the Department of Surgery and director of Genitourinary Oncology at the University of Montreal, said in the press release.¹ “…[Relugolix] is the first approved ADT in Canada that can be administered orally, and once daily, offering a safe and effective option for patients [with advanced prostate cancer] in the country.”

The approval of the oral gonadotropin-releasing hormone receptor antagonist was based on findings from the phase 3 HERO study (NCT03085095), in which investigators previously reported long-lasting testosterone suppression compared with leuprolide acetate, as well as a 54% decrease in major cardiovascular events.² Moreover, a secondary readout indicated that relugolix yielded a comparable castration resistance–free survival rate vs leuprolide, respectively, in patients with metastatic disease (74% vs 75%; HR, 1.03; 95% CI, 0.68-1.57; P = .84).³

Relugolix was approved by the FDA in December 2020 for the treatment of advanced prostate cancer based on data from the phase 3 HERO trial.⁴

Frequent adverse effects associated with treatment included hot flush, musculoskeletal pain, fatigue, diarrhea, and constipation, and laboratory abnormalities consisted of glucose, triglycerides, alanine aminotransferase, and aspartate aminotransferase increases, as well as hemoglobin decreases.

References

1. Sumitomo Pharma announces authorization in Canada of ORGOVYX® (relugolix) for the treatment of men with advanced prostate cancer. News release. Sumitomo Pharma Canada, Inc. October 23, 2023. Accessed October 25, 2023. https://bit.ly/497S4Ev
2. Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. Published online June 4, 2020. doi:10.1056/NEJMoa2004325
3. Myovant Sciences announces results of additional secondary endpoint of castration resistance-free survival from phase 3 HERO study of relugolix in advanced prostate cancer. News release. Myovant Sciences. September 29, 2020. Accessed October 25, 2023. https://bit.ly/40a81Gd
4. FDA approves relugolix for advanced prostate cancer. News release. FDA. December 18, 2023. Accessed October 25, 2023. https://bit.ly/3Q76XOZ