Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ER positive, ESR1 activating variants, HER2-negative	Invasive Breast Carcinoma	Imlunestrant