Therapeutic Response

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

Statements

Source and description
Orserdu (elacestrant) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to elacestrant for the treatment of patients who are postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Orserdu (elacestrant) [product information]. EMA. 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.