Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

Citation

Stemline Therapeutics, Inc. Orserdu (elacestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf. Revised May 2023. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, ESR1 activating variants, HER2-negative	Invasive Breast Carcinoma	Elacestrant

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-01-27	Food and Drug Administration	Indication received traditional approval.