Open AccessDarolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer
Author(s) -
Lesley J. Scott
Publication year - 2020
Publication title -
targeted oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.697
H-Index - 40
eISSN - 1776-260X
pISSN - 1776-2596
DOI - 10.1007/s11523-020-00779-x
Subject(s) - medicine , prostate cancer , androgen deprivation therapy , oncology , placebo , adverse effect , androgen receptor , cancer , alternative medicine , pathology
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.