FDA label
What is Orserdu used for?
Orserdu contains elacestrant. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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, with disease progression following at least one line of endocrine therapy.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted Orserdu?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Orserdu, tablet, film coated
Indications and Usage, quoted from the label by Stemline Therapeutics, Inc. (NDA217639). Cross-references to other label sections are left out.
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, with disease progression following at least one line of endocrine therapy.
Source: DailyMed label, set id aa66ae5c-2bd2-4444-8178-b55651e054ef, version 9, effective June 24, 2026. NDC 72187-0101, one of 2 listings for this product.
Questions
What is Orserdu used for?
The FDA label says: “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, with disease progression following at least one line of endocrine therapy.”
What drug class is Orserdu?
FDA lists elacestrant in the Estrogen Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.