Darolutamide approved by the US Food and Drug Administration (FDA) for use in the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

An androgen receptor inhibitor.

A structurally distinct androgen-receptor inhibitor.

Tradename Nubeqa

600 mg b.i.d.

Approval based on results from the phase 3 ARAMIS trial which showed a significant improvement in the primary endpoint of metastasis-free survival (MFS) in non-metastatic castrate resistant prostate cancer.

An androgen receptor antagonist with high affinity for both wild-type androgen receptors and androgen receptor variants associated with resistance to aplalutamide (Etleara) and enzalutamide (Xtandi) in pre-clinical studies.

ARAMIS 3 Trial treated patients with ADT and Darolutamide in patients with high-risk nonmetastatic castration resistant prostate cancer resulting in improved metastasis free survival.

Metastases free survival 40.4 months versus 18.4 months for placebo.

In the ARAMIS study the percentage of patients who were alive at three years was significantly higher among those who received daralutamide than among those who received placebo.

ARASENS trial of patients with metastatic hormone sensitive prostate cancer, the overall survival was significantly longer with the combination of Darolutamide, androgen deprivation therapy, and docetaxel than with placebo plus androgen deprivation and docetaxel: addition of Darolutamide led to improvement in key secondary endpoints: suggested to be come a new standard of care for the treatment of patients with metastatic hormone sensitive prostate cancer.

Among patients with metastatic hormone sensitive prostate cancer patient to receive darolutamide added to androgen deprivation therapy and docetaxel had longer survival in those who receive placebo.

Less likely than other  second line androgen receptor inhibitors to cause fractures, falls, dizziness, cognitive impairment or seizures (Apalutamide, Enzalutamide).


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