The FDA has accepted a supplemental New Drug Application (sNDA) for darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
This sNDA is based on positive results from the phase 3 ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiographic progression or death compared to placebo plus ADT. Darolutamide's safety profile was consistent with previous findings, and no new safety signals were identified. If approved, this would expand darolutamide's indication in mHSPC to include use with and without chemotherapy.
Darolutamide is currently FDA-approved for use in mHSPC in combination with docetaxel and as monotherapy for patients with nonmetastatic castration-resistant prostate cancer. The ARANOTE trial was a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of darolutamide plus ADT compared to placebo plus ADT in patients with mHSPC.
