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02-08-2019 | Oncology | News | Article

approvalsWatch

Darolutamide added to armamentarium for nonmetastatic CRPC

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.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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