On August 5, 2022, the FDA accelerated the approval of darolutamide (Nubeqa; Bayer Healthcare), an androgen receptor inhibitor, in combination with docetaxel, for the treatment of metastatic hormone-sensitive prostate cancer in adults.
Darolutamide was previously approved for nonmetastatic castration-resistant prostate cancer.
The approval of this new indication was based on results of the randomized, multicenter, double-blind, placebo-controlled ARASENS phase 3 clinical trial of 1306 patients with metastatic hormone-sensitive prostate cancer. The patients received 600 mg of darolutamide orally twice daily plus 75 mg/m2 of docetaxel intravenously every 3 weeks for up to 6 cycles or docetaxel plus placebo.
The main end point was overall survival (OS); the secondary end point was time to pain progression. The median OS was not reached in the darolutamide arm versus 48.9 months (95% confidence interval [CI], 44.4-not reached) in the placebo arm (95% CI, 0.57-0.80; P <.0001).