Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ER positive, HER2-negative status confers therapeutic sensitivity to Letrozole in patients with Invasive Breast Carcinoma.

The Republic of Ireland's Health Products Regulatory Authority (HPRA) has authorized letrozole for the neo-adjuvant treatment of patients who are postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery is not indicated.

This statement is based on a regulatory approval from the Health Products Regulatory Authority:

Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.

Citation

Novartis Ireland Limited. Femara 2.5 mg film-coated tablets (Letrozole) [summary of product characteristics]. Health Products Regulatory Authority website. https://assets.hpra.ie/products/Human/22619/Licence_PA0896-012-001_30082024144429.pdf. Revised August 2024. Accessed May 25, 2025.