Regulatory approval

Published by the European Medicines Agency. Approved

Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

This is written in the approval document.

Citation

Novartis Europharm Limited. Afinitor (everolimus) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf. Revised June 2022. Accessed March 11, 2024.

Therapeutic response

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

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