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Apalutamide in non-metastatic castration-resistant prostate cancer: a profile of its use

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posted on 2020-02-16, 18:49 authored by Lesley J. Scott

Compliance with ethical standards

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

Conflicts of interest: Lesley Scott is a salaried employee of Adis International Ltd./Springer Nature, is responsible for the article content and declares no conflicts of interest.

Additional information about this Adis Drug Review can be found here


Apalutamide (ERLEADA®), a next-generation androgen receptor (AR) inhibitor, is approved in several countries, including those of the EU and in the USA, for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In the pivotal SPARTAN study in men with nmCRPC who were at high risk of developing metastases despite androgen-deprivation therapy (+ ADT), oral apalutamide (+ ADT) significantly prolonged metastasis-free survival (MFS) compared with placebo (+ ADT) at a median follow-up of 20.3 months, with consistent benefits demonstrated across prespecified subgroups. At this timepoint, apalutamide (+ ADT) also significantly prolonged the time to metastasis and progression-free survival (PFS) and maintained health-related quality of life (HR-QOL) compared with placebo (+ ADT). Apalutamide is generally well tolerated, with most adverse reactions of mild to moderate severity and relatively few patients discontinuing treatment because of these events. Although mature OS results are awaited with interest, given its beneficial effects on MFS and convenient oral once-daily regimen, apalutamide (+ ADT) is an important emerging treatment option for patients with nmCRPC who are at high risk of developing metastatic disease.

© Springer Nature Switzerland AG 2020


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