Bayer Receives FDA Approval for Nubeqa in Metastatic Hormone-Sensitive Prostate Cancer

Bayer today announced that the FDA has approved Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy (ADT) for the treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC). In the Phase 3 ARASENS trial, the combination demonstrated a statistically significant improvement in overall survival compared to docetaxel plus ADT. The hazard ratio for OS was 0.68, representing a 32% reduction in the risk of death. The median OS was not reached for Nubeqa plus docetaxel plus ADT versus 48.9 months for docetaxel plus ADT. This approval provides a new treatment option for patients with mHSPC.