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.
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.