The approval is supported by the safety and efficacy data from the Phase 3 HERO trial of Orgovyx in which the drug met the primary endpoint
Sumitomo Pharma gets Health Canada’s approval for Orgovyx. (Credit: Sumitomo Pharma Co., Ltd.)
Sumitomo Pharma Canada, a subsidiary of Japan-based Sumitomo Pharma, has received approval from Health Canada for Orgovyx (relugolix) for the treatment of advanced prostate cancer in men.
Orgovyx is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It is designed to block the GnRH receptor and bring down the production of testicular testosterone, which triggers the growth of prostate cancer.
The drug was approved for advanced hormone-sensitive prostate cancer by the US Food and Drug Administration (FDA) in December 2020 and by the European Commission in April last year.
Sumitomo Pharma Canada general manager Lisa Mullett said: “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.
“We are committed to making Orgovyx available to patients across Canada early in the new year.”
Health Canada’s approval is supported by the safety and efficacy data from the Phase 3 HERO trial of Orgovyx in men with advanced prostate cancer.
The randomised, open-label, parallel-group, multinational clinical trial assessed the safety and efficacy of GnRH receptor antagonist.
It recruited over 1,000 men with androgen-sensitive advanced prostate cancer who needed at least one year of continuous androgen deprivation therapy (ADT).
Orgovyx met the study’s primary endpoint. It showed superiority in sustained testosterone suppression to castrate levels through 48 weeks in comparison to the existing standard of care, leuprolide acetate injections.
The most frequent side reactions included hot flushes, musculoskeletal pain, weariness, constipation, and mild to moderate diarrhoea in at least 10% of the males subjected to Orgovyx.
University of Montreal department of surgery chairman and genitourinary oncology director Fred Saad said: “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.”