Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that TSC2 oncogenic variants status confers therapeutic sensitivity to Everolimus in patients with Anaplastic Thyroid Cancer.

The U.S. Food and Drug Administration granted approval to everolimus 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 statement is based on a regulatory approval from the Food and Drug Administration:

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.

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.