Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2018 Apr;78(6):699-705.
doi: 10.1007/s40265-018-0900-z.

Apalutamide: First Global Approval

Zaina T Al-Salama  1
Affiliations
Review

Apalutamide: First Global Approval

Zaina T Al-Salama. Drugs. 2018 Apr.

Abstract

Apalutamide (ErleadaTM) 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.

PubMed Disclaimer

References

    1. Anticancer Drugs. 2018 Apr;29(4):323-333 - PubMed
    1. N Engl J Med. 2018 Apr 12;378(15):1408-1418 - PubMed
    1. Ann Oncol. 2017 Sep 1;28(9):2264-2271 - PubMed
    1. Urology. 2018 Jan 31;:null - PubMed
    1. Cancer Discov. 2013 Sep;3(9):1020-9 - PubMed

MeSH terms