Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer
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ADIS DRUG EVALUATION
Darolutamide: A Review in Non‑Metastatic Castration‑Resistant Prostate Cancer Lesley J. Scott1 Published online: 25 November 2020 © Springer Nature Switzerland AG 2020
Abstract 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.
Darolutamide: clinical considerations in nmCRPC Second-generation AR inhibitor, with a distinct chemical structure relative to other anti-androgens Low blood-brain barrier penetration; low potential for drug-drug interaction Significantly prolongs MFS and OS vs placebo (+ ADT) Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12925682. The manuscript was reviewed by: G. Colloca, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica, Ematologia Fondazione A. Gemelli IRCCS Catholic University of Sacred Heart, Rome, Italy; T. M. de Reijke, Department of Urology, Amsterdam University Medical Centers, Amsterdam, Netherlands; F. Di Maida, Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy; N. Shore, Carolina Urologic Research Center, Myrtle Beach, SC, USA. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11523-020-00779-x) contains supplementary material, which is available to authorized users. * Lesley J. Scott [email protected] 1
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Generally well tolerated, with the nature and incidence of most AEs similar to those of placebo
1 Introduction Worldwide, prostate cancer (PC) is the second most common malignancy in men, with an estimated 1.3 million new cases in 2018 [1]. Although a high clinical cure rate is achievable with localized definitive treatment in the early stages of PC, 20–30% of men subsequently experience disease progression and require syste
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