medwireNews: US patients with metastatic hormone-sensitive prostate cancer (HSPC) can be given darolutamide alongside docetaxel plus androgen deprivation therapy (ADT) following a positive FDA recommendation.
The efficacy of the nonsteroidal antiandrogen in this patient population was demonstrated in the double-blind, phase 3 ARASENS trial. Specifically, use of darolutamide rather than placebo in combination with docetaxel plus ADT significantly prolonged the primary endpoint of overall survival as well as improving various secondary endpoints, such as time to castration-resistant prostate cancer and pain progression.
Darolutamide should be given at a dose of 600 mg twice daily with food, with docetaxel 75 mg/m2 administered every 3 weeks for up to six cycles. The FDA highlights that “[t]he first dose of docetaxel should be administered within 6 weeks after the start of darolutamide treatment.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group