Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
Efficacy was evaluated in ARANOTE (ClinicalTrials.gov Identifier: NCT02799602), a randomized, double-blind, placebo-controlled trial in 669 patients with mCSPC. Patients received