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Recent Approvals Move Needle for Nonmetastatic CRPC

Brandon Scalea
Published: Tuesday, Oct 23, 2018

Deborah A. Bradley, MD

Deborah A. Bradley, MD

Recent FDA approvals in the setting of nonmetastatic castration-resistant prostate cancer (CRPC) continue to propel the field in the right direction, but there are still unanswered questions, said Deborah A. Bradley, MD.

Most recently, the FDA approved enzalutamide (Xtandi) in July 2018 as a therapy for this patient population. The decision was based on data from the double-blind, phase III PROSPER trial, in which the combination of enzalutamide and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71% compared with ADT alone.1 Median metastasis-free survival (MFS) was 36.6 months with enzalutamide plus ADT versus 14.7 months with ADT alone (HR, 0.29; 95% CI, 0.24-0.35; P <.0001).

In February 2018, apalutamide (Erleada) became the first drug to be FDA approved for use in nonmetastatic CRPC, following the results of the phase III SPARTAN trial. This study showed a 72% decrease in the risk of metastases or death with apalutamide versus placebo.2 Median MFS was 40.5 months versus 16.2 months in the apalutamide and placebo arms, respectively (HR, 0.28; 95% CI, 0.23-0.35; P <.0001). Treatment with apalutamide was also not associated with a significant impact on quality of life.

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