US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

This article summarises FDA's rationale for determining a favourable benefit-risk assessment for elacestrant for the treatment of ER+, HER2–, ESR1-mutated metastatic breast cancer, on the basis of results from the EMERALD study.

SPS commentary:

In UK, this oral oestrogen receptor-α antagonist & degrader is licensed for use in postmenopausal women/men with ER+ve, HER2-ve locally advanced/metastatic breast cancer with an activating ESR1 mutation & disease progression after ≥1 line of endocrine therapy including CDK 4/6 inhibitor.

Journal of Clinical Oncology