Afinitor (everolimus) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Novartis Pharmaceuticals Corporation. Afinitor (everolimus) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf. Revised July 2012. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Everolimus, Exemestane
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane