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01-04-2018 | AdisInsight Report

Apalutamide: First Global Approval

Author: Zaina T. Al-Salama

Published in: Drugs | Issue 6/2018

Abstract

Apalutamide (Erleada^TM) is a next-generation oral androgen receptor (AR) inhibitor that is being developed by Janssen for the treatment of prostate cancer (PC). It binds directly to the ligand-binding domain of the AR and blocks the effects of androgens. In February 2018, apalutamide received its first global approval in the USA for the treatment of non-metastatic castration-resistant PC (nmCRPC). Apalutamide is undergoing phase III investigation in chemotherapy-naive patients with metastatic CRPC (in combination with abiraterone acetate plus prednisone), patients with high-risk localized or locally advanced PC receiving primary radiation therapy, and in patients with metastatic hormone-sensitive PC and biochemically-relapsed PC. This article summarizes the milestones in the development of apalutamide leading to this first approval in nmCRPC.

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Title: Apalutamide: First Global Approval
Author: Zaina T. Al-Salama
Publication date: 01-04-2018
Publisher: Springer International Publishing
Published in: Drugs / Issue 6/2018
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-018-0900-z

At a glance: The STEP trials

Springer Medicine

Apalutamide: First Global Approval

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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