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
相关论文
共 14 条
[11]   Non-metastatic castrate-resistant prostate cancer: a call for improved guidance on clinical management [J].
Rozet, Francois ;
Roumeguere, Thierry ;
Spahn, Martin ;
Beyersdorff, Dirk ;
Hammerer, Peter .
WORLD JOURNAL OF UROLOGY, 2016, 34 (11) :1505-1513
[12]   Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer [J].
Smith, Matthew R. ;
Saad, Fred ;
Chowdhury, Simon ;
Oudard, Stephane ;
Hadaschik, Boris A. ;
Graff, Julie N. ;
Olmos, David ;
Mainwaring, Paul N. ;
Lee, Ji Youl ;
Uemura, Hiroji ;
Lopez-Gitlitz, Angela ;
Trudel, Geralyn C. ;
Espina, Byron M. ;
Shu, Youyi ;
Park, Youn C. ;
Rackoff, Wayne R. ;
Yu, Margaret K. ;
Small, Eric J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (15) :1408-1418
[13]   Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort [J].
Smith, Matthew R. ;
Antonarakis, Emmanuel S. ;
Ryan, Charles J. ;
Berry, William R. ;
Shore, Neal D. ;
Liu, Glenn ;
Alumkal, Joshi J. ;
Higano, Celestia S. ;
Maneval, Edna Chow ;
Bandekar, Rajesh ;
de Boer, Carla J. ;
Yu, Margaret K. ;
Rathkopf, Dana E. .
EUROPEAN UROLOGY, 2016, 70 (06) :963-970
[14]  
US FDA, 2018, ERL AP PRESCR INF