New EMA-approval for darolutamide

Since July 21, 2025 darolutamide is indicated for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).¹

EMA-approval is based on the results of the phase III ARANOTE study, which demonstrated that darolutamide in combination with ADT resulted in a significant improvement in radiographic progression-free survival (rPFS) vs placebo plus ADT (HR[95%CI]: 0.54[0.41-0.71], p< 0.0001) in patients with mHSPC, with consistent benefits across subgroups, including high- and low-volume disease.²

The recent EMA-approval of darolutamide plus ADT adds on to the two prior approved indications for the treatment of:

• non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease
• mHSPC in combination with docetaxel and ADT

The novel approval thus implies that darolutamide can now be used with or without chemotherapy, offering physicians greater flexibility to tailor treatment plans to meet the unique needs of their patients with mHSPC.¹

References

1. https://www.bayer.com/media/en-us/bayers-nubeqa-darolutamide-receives-eu-approval-in-third-indication-for-patients-with-advanced-prostate-cancer/
2. Saad F, et al. J Clin Oncol. 2024;42(36):4271-4281.