Afinitor (everolimus) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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