The Medical Letter on Drugs and Therapeutics
Apalutamide (Erleada) for Prostate Cancer (online only)
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Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.

CLINICAL STUDIES — Approval was based on the results of a randomized, double-blind, placebo-controlled trial (SPARTAN) in 1207 men with nonmetastatic castration-resistant prostate cancer who were at high risk for development of metastasis (a prostate-specific antigen [PSA] doubling time of ≤10 months during continuous androgen-deprivation therapy). Conventional imaging was used to rule out the presence of metastases; it is possible that many of these patients with rapidly rising PSA levels already had metastatic disease that might have been detected if more sensitive imaging modalities ... more      

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Title: Apalutamide (Erleada) for Prostate Cancer (online only)
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