Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Everolimus, Exemestane
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2012-07-20	Food and Drug Administration	Indication received traditional approval.