Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, ESR1 oncogenic variants, HER2-negative status confers therapeutic sensitivity to Elacestrant in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized elacestrant for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
This statement is based on a regulatory approval from the European Medicines Agency:
ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.