The FDA has approved a supplemental new drug application for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer.
The approval is based on findings from the phase III ARCHES trial, in which the median radiographic progression-free survival (rPFS) in men with metastatic castration-sensitive prostate cancer was not reached with enzalutamide plus androgen deprivation therapy (ADT) and was 19.45 months with placebo and ADT, translating to a 61% reduction in risk of radiographic progression or death with enzalutamide (HR, 0.39; 95% CI, 0.30-0.50; P
"Men with metastatic castration-sensitive prostate cancer face complex treatment decisions and it is critical for physicians and patients to have as much information as possible when deciding on all of the options available," lead study investigator Andrew Armstrong, MD, professor of medicine, surgery, pharmacology and cancer biology, director of Research in the Duke Cancer Institute's Center for Prostate and Urologic Cancers, stated in a press release. "The research supporting the FDA approval and updated treatment guidelines provide physicians and patients with compelling evidence to consider enzalutamide as a treatment option for men with this disease."
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