Bayer has submitted an application to the European Medicines Agency (EMA) seeking approval for its oral androgen receptor inhibitor, darolutamide, to be used in combination with androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide, marketed as Nubeqa™, is already approved for mHSPC in combination with ADT and docetaxel across more than 80 countries, and for non-metastatic castration-resistant prostate cancer (nmCRPC) in over 85 countries, where it is used with ADT to help high-risk patients prevent metastatic disease.
“Each case of metastatic hormone-sensitive prostate cancer is unique, and it’s vital for doctors to have various treatment options available to meet individual patient needs, whether involving chemotherapy or not,” stated Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer. She emphasized the company’s goal to redefine living with prostate cancer across different stages, aiming to extend survival and delay disease progression while preserving quality of life.
The submission is backed by results from the Phase III ARANOTE trial, which demonstrated that combining darolutamide with ADT significantly reduced the risk of radiological progression or death by 46% compared to a placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001). The benefits in radiological progression-free survival (rPFS) were consistent across various patient groups, including those with both high- and low-volume mHSPC. Treatment-related adverse events were minimal and similar across groups, reaffirming darolutamide’s established safety profile as observed in the ARAMIS and ARASENS trials. The ARANOTE results were presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology.
