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 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.
This statement is based on a regulatory approval from the Food and Drug Administration:
ORSERDU is an estrogen receptor antagonist indicated for treatment of 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.