Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	TSC1 oncogenic variants	Renal Angiomyolipoma	Everolimus
Sensitivity (+)	TSC2 oncogenic variants	Renal Angiomyolipoma	Everolimus