Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized fulvestrant as a monotherapy for the treatment of patients who are postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer. These patients should not have been previously treated with endocrine therapy, or have had disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.

This is written in the approval document as:

Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.

Citation

AstraZeneca AB. Faslodex (fulvestrant) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf. Revised August 2022. Accessed March 12, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ER positive	Invasive Breast Carcinoma	Fulvestrant

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2004-03-09	European Medicines Agency	Indication received approval from the European Commission.