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Apalutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer

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Abstract

Apalutamide (marketed as Erleada®) is an oral non-steroidal next-generation selective inhibitor of the androgen receptor (AR), and is approved in several countries, including the USA and those of the EU, for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In men with nmCRPC who were receiving androgen-deprivation therapy (ADT) and had a high risk of metastases in SPARTAN, apalutamide significantly prolonged metastasis-free survival (MFS) compared with placebo, with consistent benefits demonstrated across subgroups. The addition of apalutamide to ongoing ADT significantly prolonged time to metastasis and progression-free survival (PFS) compared with placebo, and maintained health-related quality of life (HR-QOL). Apalutamide was generally well tolerated in SPARTAN, with fatigue being the most frequently reported adverse event. Given the available evidence, apalutamide with ongoing ADT represents an emerging treatment option for patients with nmCRPC who are at high risk of developing metastatic disease.

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Acknowledgements

During the peer review process, the manufacturer of apalutamide was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Zaina T. Al-Salama

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  1. Zaina T. Al-Salama
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Correspondence to Zaina T. Al-Salama.

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

Conflicts of interest

Zaina T. Al-Salama is a salaried employee of Adis International Ltd/Springer Nature is responsible for the article content and declares no relevant conflicts of interest

Additional information

Additional information for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.9037439.

The manuscript was reviewed by:T.M. de Reijke, Department of Urology, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands; U. Emmenegger, Sunnybrook Odette Cancer Centre, Division of Medical Oncology, University of Toronto, Toronto, ON, Canada; N. Shore, Carolina Urologic Research Center, Myrtle Beach, SC, USA.

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Al-Salama, Z.T. Apalutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. Drugs 79, 1591–1598 (2019). https://doi.org/10.1007/s40265-019-01194-x

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