Therapeutic Response

ER positive, ESR1 activating variants, and HER2-negative status confers therapeutic sensitivity to Imlunestrant in patients with Invasive Breast Carcinoma.

Statements

Source and description
Inluriyo (imlunestrant) [package insert]. FDA. 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.
Inluriyo (imlunestrant) [product information]. EMA. The European Medicines Agency (EMA) has authorized imlunestrant as a monotherapy for the treatment of adult patients with estrogen receptor (ER-positive), HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. The EPAR notes that in pre- or perimenopausal women, or men, imlunestrant should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Furthermore, it notes that patients should be selected based on the presence of an activating ESR1-variant in tumor or in plasma specimens, using a CE-marked in vitro diagnostic with the corresponding intended purpose or an alternative validated test.