Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-09-15	European Medicines Agency	Indication received approval from the European Commission.