Posted by Michael Wonder on 05 Aug 2022
FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer
5 August 2022 - On 5 August 2022, the FDA approved darolutamide (Nubeqa, Bayer) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.
Efficacy was based on ARASENS, a randomised, multi-centre, double-blind, placebo-controlled clinical trial in 1306 patients with metastatic hormone-sensitive prostate cancer.
