Health
Health Canada grants marketing authorization for an additional indication of Bayer's NUBEQA® (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC)
Bayer Inc. is pleased to announce that Health Canada has granted marketing authorization for its oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide)1 for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). This marketing authorization is based on results from the pivotal2 Phase III ARANOTE trial, which showed that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71
About this update from Bayer Ag
[{"type":"list","items":[{"val":[{"type":"text","content":"Today's marketing authorization is based on recent results from the Phase III ARANOTE trial and broadens the indication profile of darolutamide in metastatic hormone-sensitive prostate cancer (mCSPC), enabling its use in combination with ADT, with or without chemotherapy (docetaxel)","length":287,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":287,"olType":false},{"type":"text","content":"MISSISSAUGA, ON, Aug. 21, 2025 /CNW/ - Bayer Inc. is pleased to announce that Health Canada has granted marketing authorization for its oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide)1 for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). This marketing authorization is based on results from the pivotal2 Phase III ARANOTE trial, which showed that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mCSPC.","length":587,"tagName":"p"},{"type":"image","alt":"Bayer Inc. (CNW Group/Bayer Inc.)","displaySize":"","headline":null,"caption":"Bayer Inc. (CNW Group/Bayer Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":223,"height":223,"url":"https://media.zenfs.com/en/cnwgroup.com/104f1798e484654c3d5c8d19a8f86229"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/RLXMsoIuUp6xtUl4xguoag--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTQyMDtjZj13ZWJw/https://media.zenfs.com/en/cnwgroup.com/104f1798e484654c3d5c8d19a8f86229","width":223,"height":223}},"href":"https://mma.prnewswire.com/media/2754924/Bayer_Inc__Health_Canada_grants_marketing_authorization_for_an_a.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"With this additional marketing authorization, darolutamide plus ADT is the first and only ARi indicated in Canada for the treatment of adult patients with mCSPC, either with or without docetaxel. In addition, darolutamide is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.","length":391,"tagName":"p"},{"type":"text","content":""This latest authorization reaffirms NUBEQA's role as a therapy for men with prostate cancer," said Shurjeel Choudhri, Senior Vice P...