Posted by Michael Wonder on 27 Jan 2023
FDA approves elacestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
27 January 2023 - Today, the FDA approved elacestrant (Orserdu, Stemline Therapeutics) for post-menopausal women or adult men with ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with elacestrant.
