Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to elacestrant for the treatment of patients who are 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 as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, ESR1 oncogenic variants, HER2-negative	Invasive Breast Carcinoma	Elacestrant