Inluriyo (imlunestrant) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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