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An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer

2020; American Association for Cancer Research; Volume: 26; Issue: 18 Linguagem: Inglês

10.1158/1078-0432.ccr-19-3835

1557-3265

Michael H. Brave, Chana Weinstock, Jamie R. Brewer, Dow-Chung Chi, Daniel L. Suzman, Joyce Cheng, Lijun Zhang, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver,

Cancer, Lipids, and Metabolism

Abstract The FDA has approved three androgen receptor inhibitors—enzalutamide, apalutamide, and darolutamide—for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). These approvals were all based on randomized, double blind, placebo-controlled trials demonstrating large improvements in metastasis-free survival (MFS) and internally consistent evidence of benefit seen across secondary endpoints. In this article, we summarize the FDA regulatory history of MFS and we describe the design, conduct, and results of the three pivotal trials supporting these important treatment options for patients with nmCRPC.