FDA Approves Darolutamide for Men with Non-Metastatic Castration-Resistant Prostate Cancer


Darolutamide, an androgen receptor inhibitor (ARi) for the treatment of patients with non-metastatic castration-resistant prostate cancer, was approved by the FDA this week.

Officials with the FDA approved darolutamide (Nubeqa, Bayer) this week, under the federal agency’s Priority Review designation.

Darolutamide is an androgen receptor inhibitor (ARi) for the treatment of patients with non-metastatic castration-resistant prostate cancer.

The FDA's approval is based on the phase 3 ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS).

MFS had a medium of 40.4 months verses 18.4 months for placebo plus ADT. During the ARAMIS trial, both arms showed a 9% discontinuation rate due to adverse events, the most frequent in darolutamide versus placebo were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

"With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC," said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer.

Darolutamide was not studied in women, and there is a warning and precaution for embryo-fetal toxicity.


FDA approves Bayer's Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer [press release]. Bayer website. Published July 30, 2019. https://www.bayer.us/en/newsroom/press-releases/article/?id=123336. Accessed July 31, 2019.

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