Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to everolimus in combination with exemestane for the treatment of patients who are postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer after failure of treatment with letrozole or anastrozole.

This statement is based on a regulatory approval from the Food and Drug Administration:

AFINITOR is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.

Citation

Novartis Pharmaceuticals Corporation. Afinitor (everolimus) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203985s023,022334s051lbl.pdf. Revised February 2022. Accessed October 30, 2024.