Regulatory approval

Published by the Health Products Regulatory Authority. Approved

The Republic of Ireland's Health Products Regulatory Authority (HPRA) has authorized letrozole for the adjuvant treatment of patients who are postmenopausal women with hormone receptor positive invasive early breast cancer.

This is written in the approval document as:

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early 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.

Organizations	Biomarkers	Cancer types	Therapies
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

Contributions

Date	Contributor	Description
2024-11-10	Van Allen lab	Adding HRPA approvals for use to database