FDA label
What is Ibrance used for?
Ibrance contains palbociclib. The FDA-approved uses below are 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 Ibrance lists 2 uses: HER2-Negative Metastatic Breast Cancer; HER2-Positive Metastatic Breast Cancer.
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Ibrance, tablet, film coated
Indications and Usage, quoted from the label by U.S. Pharmaceuticals (NDA212436). Cross-references to other label sections are left out.
HER2-Negative Metastatic Breast Cancer
IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy; or
- fulvestrant in patients with disease progression following endocrine therapy.
IBRANCE is indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.
HER2-Positive Metastatic Breast Cancer
IBRANCE is indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
Source: DailyMed label, set id 89a142d5-7e61-48bf-9e77-e2cd124c4792, version 11, effective July 6, 2026. NDC 63539-284, one of 6 listings for this product.
Questions
What is Ibrance used for?
The FDA label for Ibrance lists 2 uses: HER2-Negative Metastatic Breast Cancer; HER2-Positive Metastatic Breast Cancer.
What drug class is Ibrance?
FDA lists palbociclib in the Kinase 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.