Regulatory approval

Published by the Food and Drug Administration. Approved

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.

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	Subependymal Giant Cell Astrocytoma	Everolimus
FDA (2)	TSC2 oncogenic variants	Subependymal Giant Cell Astrocytoma	Everolimus

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2016-01-29	Food and Drug Administration	Indication received traditional approval.
2010-10-29	Food and Drug Administration	Indication received accelerated approval.