Prostate Cancer Coverage from Every Angle

Darolutamide Granted NDA and Priority Review in Nonmetastatic Castration-Resistant Prostate Cancer

By: Sarah Jackson
Posted: Wednesday, May 8, 2019

The U.S. Food and Drug Administration (FDA) recently accepted a new drug application (NDA) and granted Priority Review to darolutamide for the treatment of nonmetastatic castration-resistant prostate cancer. Darolutamide is an investigational, nonsteroidal androgen receptor antagonist with a chemical structure that binds to the receptor, inhibiting the growth of prostate cancer cells.

The new drug application and Priority Review status were based on data from the phase III ARAMIS trial ( identifier NCT02200614) in men with nonmetastatic castration-resistant prostate cancer. ARAMIS is a randomized, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nonmetastatic castration-resistant prostate cancer who are currently being treated with androgen-deprivation therapy as the standard of care and are at high risk for developing metastatic disease. Approximately 1,500 patients were randomly assigned in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with androgen-deprivation therapy.

The primary endpoint of this trial is metastasis-free survival, which is defined as the time between randomization and evidence of metastasis or death. The secondary endpoints are overall survival, time to pain progression, time to initiation of first cytotoxic chemotherapy, time to first symptomatic skeletal event, and characterization of the safety and tolerability of darolutamide.

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