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/2012/022334s017lbl.pdf. Revised April 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 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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	TSC1 oncogenic variants	Renal Angiomyolipoma	Everolimus
FDA (1)	TSC2 oncogenic variants	Renal Angiomyolipoma	Everolimus
FDA (1)	TSC1 oncogenic variants	Subependymal Giant Cell Astrocytoma	Everolimus
FDA (1)	TSC2 oncogenic variants	Subependymal Giant Cell Astrocytoma	Everolimus