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Darolutamide

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

A 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.

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