Femara (letrozole) [summary of product characteristics]. HPRA.

Regulatory approval published by the Health Products Regulatory Authority.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. 3
Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. 3
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer. 3
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ER positive, PR positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) ER positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) PR positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) ER positive, PR positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) ER positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) PR positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) ER positive, PR positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) ER positive Invasive Breast Carcinoma Letrozole
Sensitivity (+) PR positive Invasive Breast Carcinoma Letrozole
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