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These highlights do not include all the information needed to use ORSERDU safely and effectively. See full prescribing information for ORSERDU. ORSERDU® (elacestrant) tablets, for oral use Initial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration (2.1)], with disease progression following at least one line of endocrine therapy.
- generic_name
- elacestrant
- product_names
- Elacestrant
- ndc
- 72187-0101, 72187-0101-3, 72187-0102, 72187-0102-3
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en