Therapeutic Response Statement (Sensitivity)

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

The European Medicines Agency (EMA) has authorized everolimus in combination with exemestane for the treatment of adult patients with hormone receptor-positive, HER2/neu negative advanced breast cancer in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

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

Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

Citation

Novartis Europharm Limited. Afinitor (everolimus) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf. Revised June 2022. Accessed March 11, 2024.