Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Fulvestrant, Palbociclib in patients with Invasive Breast Carcinoma.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.