21 November 2024 - Submission based on positive results from the Phase 3 ARANOTE trial which showed Nubeqa (darolutamide) plus androgen deprivation therapy significantly reduced the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer when compared to placebo plus androgen deprivation therapy; no new safety signals were observed.

Bayer today announced that the US FDA has accepted the company’s supplemental new drug application for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.

Read Bayer press release