Apalutamide: First Global Approval

被引:52
作者
Al-Salama, Zaina T. [1 ]
机构
[1] Springer, Private Bag 65901, Auckland 0754, New Zealand
关键词
RESISTANT PROSTATE-CANCER; ANTITUMOR-ACTIVITY; ARN-509; ANTIANDROGEN; SAFETY;
D O I
10.1007/s40265-018-0900-z
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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.
引用
收藏
页码:699 / 705
页数:7
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