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.

View API

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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