Regulatory approval

Published by the Health Products Regulatory Authority.

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 is written in the approval document as:

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.

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	Letrozole
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole