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<p>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−, <i>ESR1</i>-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−, <i>ESR1</i>-mutated advanced or metastatic breast cancer.</p>

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Imlunestrant: First Approval

  • 期刊论文

  • 发表日期：

    2025年12月3日

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  • Susan J. Keam

摘要

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.