Bayer (BAYRY, Financial) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for treating patients with metastatic hormone-sensitive prostate cancer (mHSPC). This sNDA submission is based on the positive results from the Phase III ARANOTE study.
The ARANOTE study was a randomized, double-blind, placebo-controlled clinical trial involving 669 participants. It aimed to evaluate the efficacy and safety of darolutamide (600mg, twice daily) combined with ADT, compared to a placebo combined with ADT, in patients with mHSPC. The primary endpoint of the study was the radiographic progression-free survival (rPFS) at 36 months.
