Orserdu (elacestrant) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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