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Agency grants priority review for prostate cancer drug
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The FDA granted priority review designation for an experimental prostate cancer drug.
Enzalutamide (Medivation Inc. and Astellas Pharma Inc.) — an androgen receptor signaling inhibitor formerly known as MDV3100 — is intended for the treatment of men with castration-resistant prostate cancer who previously underwent docetaxel-based chemotherapy.
Enzalutamide extended OS by a median 4.8 months compared with placebo (HR=0.631; P<.0001), according to results of the phase 3 AFFIRM trial.
Patients assigned to enzalutamide experienced higher rates of fatigue, diarrhea and hot flush compared with patients assigned to placebo, according to study results.
However, rates of serious adverse events, adverse events that caused patients to discontinue treatment, and adverse events that caused death were lower in the enzalutamide group than the placebo group.