Regulatory approval
Published by the Health Products Regulatory Authority.
The Republic of Ireland's Health Products Regulatory Authority (HPRA) has authorized letrozole for the extended adjuvant treatment of patients who are postmenopausal women with hormone-dependent-invasive breast cancer who have received prior standard adjuvant tamoxifen therapy for 5 years.
This is written in the approval document as:
Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
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 | Invasive Breast Carcinoma | Letrozole | |
| Sensitivity (+) | PR positive | Invasive Breast Carcinoma | Letrozole | |
| Sensitivity (+) | ER positive, PR positive | Invasive Breast Carcinoma | Letrozole |