Bayer's Third Prostate Cancer Indication to FDA

Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets around the world. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world. In September 2024, sales of Nubeqa exceeded sales of one billion euros year-to-date.

Results from the Phase III ARANOTE trial showed that darolutamide plus ADT significantly 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 mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high- and low-volume mHSPC. Treatment-emergent adverse events (TEAEs) were low and similar between treatment groups and the safety analysis reconfirmed the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials. The ARANOTE results were simultaneously presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology. (previously cited).