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 supported by data from the phase 3 ARANOTE trial.

The ARANOTE trial demonstrated positive results for darolutamide plus ADT, showing a 46% reduction in the risk of radiographic progression or death compared to placebo plus ADT. The trial also showed a favorable safety profile for darolutamide, consistent with previous findings, and no new safety signals were identified.
Darolutamide is already FDA-approved for use in mHSPC in combination with docetaxel and as a monotherapy for patients with nonmetastatic castration-resistant prostate cancer. If this sNDA is approved, it would expand the indication for darolutamide in mHSPC to include use with and without chemotherapy.
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.
The primary endpoint of the study was radiographic progression-free survival (rPFS). Secondary endpoints included overall survival (OS), time to castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to PSA progression, PSA undetectable rates, time to pain progression, and safety.

In addition to the ARANOTE trial, darolutamide is being evaluated in two other phase 3 trials:
● The ARASTEP trial is investigating darolutamide in combination with ADT for the treatment of patients with high-risk biochemical recurrence HSPC with no metastatic disease detected by conventional imaging.
● The DASL-HiCaP study is evaluating adjuvant darolutamide for the potential treatment of patients with localized prostate cancer at high risk of recurrence.

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