26 September 2024 - Submission is based on positive results from the investigational pivotal Phase 3 ARANOTE trial that showed Nubeqa (darolutamide) plus androgen deprivation therapy demonstrated an improvement in radiological progression-free survival significantly reducing in the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer compared to placebo plus androgen deprivation therapy; no new safety signals were observed.

Bayer today announced the submission of a supplemental new drug application to the US FDA 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