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FDA Sets Action Date for Enzalutamide for Treatment of Prostate Cancer
On July 24, the companies had announced that the FDA had accepted the enzalutamide NDA filing for review and had granted Priority Review Designation.
Enzalutamide is an oral, once-daily, investigational androgen receptor signaling inhibitor. The drug inhibits androgen receptor signaling by inhibiting 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.
In the phase III AFFIRM trial, side effects observed more frequently with enzalutamide compared with placebo included fatigue, diarrhea, and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death were lower in the enzalutamide group than in the placebo group.
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