Regulatory approval

Published by the Food and Drug Administration. Approved

AFINITOR is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Everolimus, Exemestane
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Everolimus, Exemestane
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Everolimus, Exemestane