FDA approves apalutamide for castration-resistant nonmetastatic prostate cancer


The Food and Drug Administration has approved apalutamide for the treatment of patients with castration-resistant nonmetastatic prostate cancer.

Approval was based on a median metastasis-free survival for patients taking apalutamide of 40.5 months, compared with 16.2 months for patients taking a placebo in a randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer. All patients also received hormone therapy, either with gonadotropin-releasing hormone analogue therapy or with surgical castration.

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This is the first FDA approval based on the endpoint of metastasis-free survival, the FDA said in a press statement.

Common side effects of apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures, and peripheral edema.

Severe side effects of apalutamide include falls, fractures. and seizures, the FDA said.

Apalutamide is marketed as Erleada by Janssen Biotech.

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