Afinitor (everolimus) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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
AFINITOR is a kinase inhibitor indicated for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.	2
AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
Sensitivity (+)	TSC1 oncogenic variants	Renal Angiomyolipoma	Everolimus
Sensitivity (+)	TSC2 oncogenic variants	Renal Angiomyolipoma	Everolimus
Sensitivity (+)	TSC1 oncogenic variants	Anaplastic Thyroid Cancer	Everolimus
Sensitivity (+)	TSC2 oncogenic variants	Anaplastic Thyroid Cancer	Everolimus