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Drugs

Imlunestrant: First Approval

Published in:
Author
Susan J. Keam
Published in
Drugs | Issue 1/2026

Abstract

Imlunestrant (Inluriyo™), an oral, selective, estrogen receptor (ER) degrader (SERD), is being developed by Eli Lilly and Company for the treatment of ER-positive (ER+), human epidermal growth factor receptor 2 (HER2) negative (HER2−) breast cancer. In September 2025, imlunestrant was approved for the treatment of adults with ER+, HER2−, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy in the USA. This article summarizes the milestones in the development of imlunestrant leading to this first approval for use in patients with ER+, HER2−, ESR1-mutated advanced or metastatic breast cancer.
Title
Imlunestrant: First Approval
Author
Susan J. Keam
Publication date
03-12-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 1/2026
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02266-x
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Keynote webinar | Spotlight on dry eye disease

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DED is highly prevalent yet challenging to diagnose and treat. Join leading experts to explore the latest developments and gain practical guidance on effective management in busy clinical settings. Brought to you by Springer Medicine and Eye.

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