Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

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	Everolimus, Exemestane
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane