Regulatory approval

Published by the Health Products Regulatory Authority.

The Republic of Ireland's Health Products Regulatory Authority (HPRA) has authorized letrozole for the first-line treatment of patients who are postmenopausal women with hormone-dependent advanced breast cancer.

This is written in the approval document as:

First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HPRA (1)	ER positive, PR positive	Invasive Breast Carcinoma	Letrozole
HPRA (1)	ER positive	Invasive Breast Carcinoma	Letrozole
HPRA (1)	PR positive	Invasive Breast Carcinoma	Letrozole