Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.