Regulatory approval

Published by the Health Products Regulatory Authority.

The Republic of Ireland's Health Products Regulatory Authority (HPRA) has authorized exemestane for the adjuvant treatment of patients who are postmenopausal women with hormone receptor-positive invasive early breast cancer (EBC) who have received 2 to 3 years of initial tamoxifen therapy.

This is written in the approval document as:

Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy.

Citation

Pfizer Healthcare Ireland. Aromasin 25 mg coated tablets (Exemestane) [summary of product characteristics]. Health Products Regulatory Authority website. https://assets.hpra.ie/products/Human/23117/Licence_PA0822-111-001_09012025155108.pdf. Revised January 2025. Accessed May 25, 2025.

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ER positive Invasive Breast Carcinoma Exemestane