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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	ER positive, ESR1 oncogenic variants, HER2-negative	Invasive Breast Carcinoma	Elacestrant