Darolutamide (Nubeqa) was approved by the Food and Drug Administration (FDA) on June 3, 2025, for the treatment of metastatic castration-sensitive prostate cancer (mCSPC).
Indication:
mCSPC in combination with androgen deprivation therapy (ADT)
Dosage:
600 mg twice daily with food
Clinical Trial Results:
The ARANOTE trial investigated darolutamide in combination with androgen deprivation therapy (ADT) for mCSPC.Darolutamide significantly improved rPFS, with a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT.
While overall survival data was not yet mature, there was a trend favoring darolutamide.
The treatment was well-tolerated with a low incidence of adverse events and treatment discontinuations, comparable to placebo.