Orserdu (elacestrant) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Stemline Therapeutics, Inc. Orserdu (elacestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217639Orig1s001correctedlbl.pdf. Revised January 2023. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
ORSERDU is an estrogen receptor antagonist indicated for treatment of postmenopausal 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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER positive, ESR1 activating variants, HER2-negative	Invasive Breast Carcinoma	Elacestrant