Nubega OK’d as Single Agent in Prostate Cancer

FDA has approved a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive prostate cancer (mCSPC). The drug was previously approved in combination with docetaxel for mCSPC.

Approval was based on data from the ARANOTE (NCT02799602) trial in 669 patients with mCSPC. Patients received either darolutamide or placebo, according to an FDA release. All patients received a gonadotropin-releasing hormone analog concurrently or had prior bilateral orchiectomy, it says.

“Treatment with darolutamide resulted in a statistically significant improvement in rPFS [radiographic progression-free survival] compared to placebo,” the release says. It notes that median rPFS was not reached in the darolutamide arm and was 25 months in the placebo arm.

Adverse reactions were consistent with prior use of darolutamide as a single agent, FDA says.