Ibrance (palbociclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Pfizer, Inc. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf. Revised February 2016. Accessed October 6, 2026.

Regulatory approvals

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

Indication	Statements
IBRANCE is a kinase inhibitor 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 fulvestrant in patients with disease progression following endocrine therapy.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib