Apalutamide (Erleada®) is an oral selective androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC). In a multinational, phase III study (TITAN) in this patient population, the addition of apalutamide (240 mg once daily) to androgen deprivation therapy (ADT) significantly improved median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy, while maintaining health-related quality of life (HR-QOL) and not substantially differing from placebo plus ADT in safety. Although mature OS data are awaited with interest, the addition of apalutamide to ADT extends the treatment options available for standard of care in adult men with mCSPC.
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During the peer review process, the manufacturer of the agent under review was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest
Sheridan Hoy is a salaried employee of Adis International Ltd/Springer Nature and declares no conflict of interest. All authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability
Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12838184.
The manuscript was reviewed by: P. Barata, Tulane University School of Medicine, New Orleans, LA, USA; A. Jang, Tulane University School of Medicine, New Orleans, LA, USA; M. Marchioni, Urology Unit, Department of Medical, Oral and Biotechnological Sciences, G. D’Annunzio University of Chieti, Chieti, Italy.
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Hoy, S.M. Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer. Drugs 80, 1579–1585 (2020). https://doi.org/10.1007/s40265-020-01401-0