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.

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Therapeutic response

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

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