Darolutamide: a review in non-metastatic castration-resistant prostate cancer

<p><b>Declarations</b><br></p> <p><b>Funding</b> The preparation of this review was not supported by any external funding.</p> <p> </p> <p><b>Authorship and Conflict of interest</b> Lesley Scott 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.</p> <p> </p> <p><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> Not applicable</p><p><br></p><p><br></p><p>Additional information about this Adis Drug Review can be found here<br></p><p><br></p><p>Abstract</p><p></p><p>Oral darolutamide (Nubeqa™) is a novel second-generation, nonsteroidal, selective androgen receptor (AR) inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In the pivotal multinational, phase 3 ARAMIS trial in men with nmCRPC, relative to placebo plus ongoing androgen deprivation therapy (ADT), darolutamide (+ ADT) significantly prolonged metastasis-free survival (MFS) at the time of the primary analysis and overall survival (OS) at the time of the final OS analysis and was generally well tolerated in extended follow-up. Albeit long-term data from the real-world setting are required to fully define the safety profile of darolutamide, current evidence from the final ARAMIS analysis indicates that darolutamide has a low propensity for CNS-related adverse events (AEs) associated with other currently approved second-generation AR inhibitors. Given the efficacy and safety evidence from the final ARAMIS analysis and the key role of second-generation AR inhibitors in the management of nmCRPC, darolutamide + ADT represents an important emerging option for the treatment of men with nmCRPC who are at high risk of developing metastatic prostate cancer.</p><p>© Springer Nature Switzerland AG 2020</p><br><p></p>