medwireNews: Darolutamide is the latest nonsteroidal antiandrogen to receive a positive decision from the US FDA for the treatment of men with nonmetastatic castration-resistant prostate cancer (CRPC).
The FDA has previously approved enzalutamide and apalutamide for the same indication.
The current decision is based on the phase III ARAMIS trial that showed a significant improvement in metastasis-free survival with darolutamide versus placebo, given alongside a gonadotropin-releasing hormone (GnRH) analog or following a bilateral orchiectomy.
The oral antiandrogen should be given at a dose of 600 mg twice daily, and men are required to receive a GnRH analog concomitantly or have undergone bilateral orchiectomy.
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