medwireNews: The US FDA has expanded the indication for enzalutamide to include men with nonmetastatic castration-resistant prostate cancer (CRPC).
Previously approved for men with metastatic CRPC, the update follows findings from the PROSPER study, where CRPC patients using the nonsteroidal anti-androgen agent achieved significantly longer metastasis-free survival than those given placebo.
Enzalutamide is recommended at a dose of 160 mg/day and is associated with side effects including fatigue, hot flash, hypertension, dizziness, nausea, and falls.
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