FDA label
What is letrozole used for?
The FDA-approved uses of letrozole, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for letrozole lists 3 uses: Adjuvant Treatment of Early Breast Cancer; Extended Adjuvant Treatment of Early Breast Cancer; First and Second-Line Treatment of Advanced Breast Cancer.
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Letrozole, tablet, film coated
Indications and Usage, quoted from the label by Accord Healthcare, Inc. (ANDA090934). Cross-references to other label sections are left out.
Adjuvant Treatment of Early Breast Cancer
Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
Extended Adjuvant Treatment of Early Breast Cancer
Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival (DFS) in patients treated with letrozole tablets for a median of 60 months.
First and Second-Line Treatment of Advanced Breast Cancer
Letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Source: DailyMed label, set id c391fe11-fd47-4a35-af6d-c823ab7b8838, version 13, effective February 9, 2026. NDC 16729-034, one of 18 listings for this product.
Questions
What is letrozole used for?
The FDA label for letrozole lists 3 uses: Adjuvant Treatment of Early Breast Cancer; Extended Adjuvant Treatment of Early Breast Cancer; First and Second-Line Treatment of Advanced Breast Cancer.
What drug class is letrozole?
FDA lists letrozole in the Aromatase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.