FDA Approval Alert: The Need-to-Know | Elacestrant for ER+/HER2– Advanced Metastatic Breast Cancer
In January 2023, the FDA approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression after at least 1 line of therapy.
The FDA has approved Guardant 360 CDx as a companion diagnostic for elacestrant in patients with ESR1-mutant, estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer.
Patients with estrogen receptor–positive, HER2-negative metastatic breast cancer can now receive elacestrant as treatment following the FDA’s approval of the agent.