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Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer

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posted on 2023-08-07, 00:24 authored by Arnold Lee


Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Arnold Lee is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here


Darolutamide (NUBEQA®) is an oral androgen receptor inhibitor (ARi) that is approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) and docetaxel. In a pivotal trial, darolutamide plus ADT and docetaxel was superior to placebo plus ADT and docetaxel in prolonging the primary endpoint of overall survival, with improvements also reported in most secondary endpoints. Treatment with darolutamide plus ADT and docetaxel was associated with a manageable tolerability profle. Furthermore, the adverse events reported with darolutamide plus ADT and docetaxel were generally consistent with the safety profles previously reported for ADT and docetaxel. Darolutamide expands the availability of treatment options in mHSPC and may be useful as a treatment for high-volume disease (typically defned as ≥ 4 bone metastases with spread outside of the pelvis and vertebral column). 

© Springer Nature Switzerland AG 2023 


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