Sumitomo Pharma gets Canadian approval for Orgovyx
Medicines regulator Health Canada has approved Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer, Japanese drugmaker Sumitomo Pharma (TYO: 4506) announced.
The company noted that the approval is based on efficacy and safety data from the Phase III HERO study of Orgovyx in men with advanced prostate cancer. Orgovyx is expected to be available for prescription in Canada in the first quarter of 2024.
Orgovyx was previously approved by the US Food and Drug Administration in December 2020 and was granted marketing authorization by the European Commission for advanced hormone-sensitive prostate cancer in April 2022.
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