Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, ESR1 activating variants, HER2-negative status confers therapeutic sensitivity to Imlunestrant in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen 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.