Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ER positive, ESR1 oncogenic variants, HER2-negative status confers therapeutic sensitivity to Imlunestrant in patients with Invasive Breast Carcinoma.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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.