Apalutamide: First Global Approval.

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Al-Salama ZT

Apalutamide: First Global Approval.

Drugs. 2018 Apr;78(6):699-705. doi: 10.1007/s40265-018-0900-z.

PubMed ID

29626324 [ View in PubMed

]

Abstract

Apalutamide (Erleada(TM)) is a next-generation oral androgen receptor (AR) inhibitor that is being developed by Janssen for the treatment of prostate cancer (PC). It binds directly to the ligand-binding domain of the AR and blocks the effects of androgens. In February 2018, apalutamide received its first global approval in the USA for the treatment of non-metastatic castration-resistant PC (nmCRPC). Apalutamide is undergoing phase III investigation in chemotherapy-naive patients with metastatic CRPC (in combination with abiraterone acetate plus prednisone), patients with high-risk localized or locally advanced PC receiving primary radiation therapy, and in patients with metastatic hormone-sensitive PC and biochemically-relapsed PC. This article summarizes the milestones in the development of apalutamide leading to this first approval in nmCRPC.

DrugBank Data that Cites this Article

Drug Enzymes

Drug	Enzyme	Kind	Organism	Pharmacological Action	Actions
Apalutamide	Cytochrome P450 2C8	Protein	Humans	No	Substrate	Details
Apalutamide	Cytochrome P450 3A4	Protein	Humans	No	Substrate Inducer	Details