Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that TSC2 oncogenic variants status confers therapeutic sensitivity to Everolimus in patients with Renal Angiomyolipoma.

The U.S. Food and Drug Administration granted approval to everolimus for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

This statement is based on a regulatory approval from the Food and Drug Administration:

AFINITOR is a kinase inhibitor indicated for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

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. 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.

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2016-02-16	Food and Drug Administration	Indication received traditional approval.
2012-04-26	Food and Drug Administration	Indication received accelerated approval.