Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized everolimus in combination with exemestane for the treatment of adult patients with hormone receptor-positive, HER2/neu negative advanced breast cancer in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Everolimus, Exemestane
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane