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FEBRUARY 5, 2023

Orserdu Approved for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer


Originally published by our sister publication Clinical Oncology News

By Kate O'Rourke

The FDA has approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for