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 treatment with elacestrant.
Efficacy was evaluated in EMERALD, a multicenter, randomized,
FEBRUARY 3, 2023