Regulatory approval

Published by the Food and Drug Administration. Approved

INLURIYO is an estrogen receptor antagonist indicated for treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

This is written in the approval document.

Citation

Eli and Lily Company. Inluriyo (imlunestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218881s000lbl.pdf. Revised September 2025. Accessed October 2, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, ESR1 activating variants, HER2-negative	Invasive Breast Carcinoma	Imlunestrant

Contributions

Date	Contributor	Description
2025-10-02	Van Allen lab	On 2025-09-25, the US FDA granted approval to Inluriyo (imlunestrant) for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
2025-09-25	Food and Drug Administration	Indication received traditional approval.