Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized elacestrant for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

This is written in the approval document as:

ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Citation

Stemline Therapeutics B.V. Orserdu (elacestrant) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf. Revised February 2024. Accessed March 22, 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