Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration (FDA) granted approval to 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.

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. 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 6, 2026.

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.