Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized imlunestrant as a monotherapy for the treatment of adult patients with estrogen receptor (ER-positive), HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. The EPAR notes that in pre- or perimenopausal women, or men, imlunestrant should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Furthermore, it notes that patients should be selected based on the presence of an activating ESR1-variant in tumor or in plasma specimens, using a CE-marked in vitro diagnostic with the corresponding intended purpose or an alternative validated test.

This is written in the approval document as:

Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER -positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen.

Citation

Eli Lilly Nederland B.V. Inluriyo (imlunestrant) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/inluriyo-epar-product-information_en.pdf. Revised February 2026. Accessed May 5, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	ER positive, ESR1 activating variants, HER2-negative	Invasive Breast Carcinoma	Imlunestrant