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These highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE. IBRANCE® (palbociclib) tablets, for oral use Initial U.S. Approval: 2015
Medication labelWhy this: Advisory · dailymed-prescription
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. 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.
- generic_name
- palbociclib
- product_names
- palbociclib
- ndc
- 0069-0284, 0069-0486, 0069-0688, 0069-0284-07, 0069-0284-03, 0069-0486-07, 0069-0486-03, 0069-0688-07, 0069-0688-03
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en