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Elacestrant Approved for ER-Positive, HER2-Negative, ESR1-Mutated Breast Cancer

The FDA has approved elacestrant (Orserdu™, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor 1 (ESR1)–mutated advanced or metastatic breast cancer with disease progression subsequent to at least one line of endocrine therapy. Additionally, the FDA approved the Guardant360 CDx assay, a companion diagnostic test, to identify breast cancer patients eligible for treatme...

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