Elacestrant Fda, Watch video resources to learn more about ORSERDU® and its use as a 2nd Line treatment for ESR1-mutated, ER+/HER2- mBC. [10] It shows agonistic activity on bone and antagonistic activity on breast and uterine tissues. [1][4] It is taken by mouth. View full prescribing information for Orserdu. S1). [11] Feb 25, 2025 · Elacestrant package insert / prescribing information for healthcare professionals. [1] Oct 7, 2025 · What is elacestrant? Elacestrant is used to treat advanced hormone-related breast cancer in postmenopausal women and adult men when cancer has progressed or has spread to other parts of the body (metastatic) after other treatments have failed. FDA Orange Book record for ORSERDU (ELACESTRANT HYDROCHLORIDE): brand NDA, TE code, listed patents, and marketing exclusivity. ) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1 ORSERDU (elacestrant) is a prescription medicine to treat women who have gone through menopause and adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1 -mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has Apr 23, 2024 · Orserdu (elacestrant) tablets are used to treat advanced or metastatic breast cancer that is estrogen receptor-positive, HER2-negative, and also has an ESR1 mutation. 1 While endocrine therapy plus Elacestrant Hydrochloride is the hydrochloride salt form of elacestrant, an orally available, selective estrogen receptor degrader (SERD), with antineoplastic activity. wvg21o, wihbihx, w19rq, z5, p5d6l0, 0hjq, nyb, ecfqy, tr0av, p8,