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Imlunestrant: First Approval.

Drugs 2026 Vol.86(1) p. 135-141

Keam SJ

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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

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BibTeX ↓ RIS ↓
APA Keam SJ (2026). Imlunestrant: First Approval.. Drugs, 86(1), 135-141. https://doi.org/10.1007/s40265-025-02266-x
MLA Keam SJ. "Imlunestrant: First Approval.." Drugs, vol. 86, no. 1, 2026, pp. 135-141.
PMID 41335371

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.

MeSH Terms

Humans; Breast Neoplasms; Drug Approval; Female; Erb-b2 Receptor Tyrosine Kinases; Estrogen Receptor alpha; United States Food and Drug Administration; United States; Antineoplastic Agents, Hormonal; Receptors, Estrogen; Tamoxifen

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