Health Canada has granted its approval to Sumitomo Pharma Canada’s Orgovyx (relugolix) to treat advanced prostate cancer in men.

Sumitomo plans to make Orgovyx available on prescription in the first quarter of 2024.

The latest development is based on findings from the Phase III HERO clinical trial of Orgovyx, an open-label, randomised, multinational, parallel-group trial that assessed the drug's efficacy and safety. 

The trial enrolled more than 1,000 male patients with androgen-sensitive advanced prostate cancer and required a minimum of sustained androgen deprivation therapy (ADT) for one year. 

Orgovyx met the primary endpoint in the trial and was demonstrated to be superior in achieving continued testosterone suppression to castrate levels for 48 weeks versus those given leuprolide acetate injections.

Leuprolide acetate injection is the existing standard of care treatment for the condition. 

Hot flushes, fatigue, musculoskeletal pain, constipation and diarrhoea were the most common adverse events reported in a minimum of 10% of men in the Orgovyx arm of the trial. 

Sumitomo Pharma Canada general manager Lisa Mullett stated: “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.”

An oral gonadotropin-releasing hormone receptor antagonist, Orgovyx received approval for treating advanced hormone-sensitive prostate cancer from the US Food and Drug Administration in December 2020 and from the European Commission in April 2022.