Health Canada approves new hormone therapy for advanced prostate cancer

Orgovyx™ (relugolix) has just obtained approval from Health Canada for the treatment of prostate cancer. Approved by the United States Food and Drug Administration in December 2020 and by the European Commission in April 2022, it will be available in Canada in the first quarter of 2024.It is “the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated against advanced prostate cancer in Canada,” reported its manufacturer, the Japanese laboratory Sumitomo Pharma, in a press release.Relugolix is taken orally in tablet form.Usually, first-line treatment for advanced prostate cancer consists of the administration of antiandrogenic agents, which reduce testosterone levels to a very low threshold, known as castration. These luteinizing hormone-releasing hormone (LHRH) analogs—the most commonly used being leuprolide (Lupron™, Lupron Depot™, Eligard™), goserelin (Zoladex™) and triptorelin (Trelstar™)—are administered by injection (once per month) or in the form of an implant placed under the skin to be changed once a year.Follows phase III trialRelugolix comes in the form of 120 mg tablets, taken once a day, and it blocks GnRH receptors, thus reducing the production of testicular testosterone which stimulates the growth of prostate cancer.Its approval by Health Canada was based on the results of the phase III HERO study, conducted in open-label mode with randomization and parallel groups. This international clinical trial aimed to evaluate the safety and effectiveness of Orgovyx in more than 1,000 men with advanced hormone-sensitive prostate cancer who were required to undergo continuous androgen deprivation therapy for at least one year.The main endpoint of the study was achieved: Relugolix proved superior to the current standard treatment, injectable leuprolide, in sustainably lowering testosterone levels to the castration threshold over 48 weeks. The most common adverse reactions, reported in at least 10% of subjects, were: flushing, musculoskeletal pain, fatigue, constipation and mild or moderate diarrhea.“Approximately one in eight Canadians will develop prostate cancer in their lifetime, and inhibition of testosterone activity, achieved primarily through antiandrogenic agents, is essential for treating advanced disease,” explained the head of the urology department and director of urological oncology at the University of Montreal Hospital Centre (CHUM), Dr. Fred Saad, cited in the Sumitomo Pharma press release. “In the HERO trial, Orgovyx resulted in rapid, profound and sustained inhibition of testosterone activity compared to leuprolide. [It] offers a safe and effective treatment option to Canadians suffering from advanced prostate cancer,” added Dr. Saad, the professor of urological surgery at the University of Montreal and holder of the Raymond Garneau Chair in prostate cancer.

Health Canada approves new hormone therapy for advanced prostate cancer

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