Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized fulvestrant in combination with palbociclib for the treatment of patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib