PMID- 33237495 OWN - NLM STAT- MEDLINE DCOM- 20211013 LR - 20220716 IS - 1776-260X (Electronic) IS - 1776-2596 (Print) IS - 1776-2596 (Linking) VI - 15 IP - 6 DP - 2020 Dec TI - Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. PG - 791-799 LID - 10.1007/s11523-020-00779-x [doi] AB - 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. FAU - Scott, Lesley J AU - Scott LJ AD - Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com. LA - eng PT - Journal Article PT - Review PL - France TA - Target Oncol JT - Targeted oncology JID - 101270595 RN - 0 (Pyrazoles) RN - 0 (darolutamide) SB - IM EIN - Target Oncol. 2022 May;17(3):381. PMID: 35511401 MH - Double-Blind Method MH - Humans MH - Male MH - Prostatic Neoplasms, Castration-Resistant/*drug therapy MH - Pyrazoles/pharmacology/*therapeutic use PMC - PMC9072426 COIS- 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. EDAT- 2020/11/26 06:00 MHDA- 2021/10/14 06:00 PMCR- 2020/11/25 CRDT- 2020/11/25 12:17 PHST- 2020/11/26 06:00 [pubmed] PHST- 2021/10/14 06:00 [medline] PHST- 2020/11/25 12:17 [entrez] PHST- 2020/11/25 00:00 [pmc-release] AID - 10.1007/s11523-020-00779-x [pii] AID - 779 [pii] AID - 10.1007/s11523-020-00779-x [doi] PST - ppublish SO - Target Oncol. 2020 Dec;15(6):791-799. doi: 10.1007/s11523-020-00779-x.