According to the Wisdom Financial APP, on November 21st, Bayer (BAYRY.US) announced that its supplemental new drug application (sNDA) for darolutamide (brand name: Nubeqa) in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) patients has been accepted by the FDA.

This sNDA is based on the positive results of the Phase III ARANOTE study. The study was a randomized, double-blind, placebo-controlled clinical trial (n=669) evaluating the efficacy and safety of darolutamide (600mg, twice daily) in combination with ADT compared to placebo in combination with ADT for the treatment of mHSPC patients. The primary endpoint of the study was radiographic progression-free survival (rPFS) at the 36th month.