Regulatory approval

Published by the European Medicines Agency. Approved

Faslodex is indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

This is written in the approval document.

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, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
EMA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
EMA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2017-11-10	European Medicines Agency	Indication received approval from the European Commission.