Regulatory approval

Published by the Food and Drug Administration. Approved

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

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)	TSC1 oncogenic variants	Renal Angiomyolipoma	Everolimus
FDA (2)	TSC2 oncogenic variants	Renal Angiomyolipoma	Everolimus

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.