Approval Alert | 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.
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Guardant360 CDx Receives Companion Diagnostic Designation in ESR1+ Breast Cancer
Jan 31, 2023 5:00 PM
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.
FDA Grants Approval to Elacestrant for ER+/HER2– Advanced Metastatic Breast Cancer
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FDA Grants Approval to Elacestrant for ER+/HER2– Advanced Metastatic Breast Cancer
Jan 27, 2023 10:05 PM
Patients with estrogen receptor–positive, HER2-negative metastatic breast cancer can now receive elacestrant as treatment following the FDA’s approval of the agent.