Ibrance (palbociclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Pfizer. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207103s024lbl.pdf. Revised June 2026. Accessed October 13, 2026.

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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 an aromatase inhibitor as initial endocrine-based therapy. 3
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
IBRANCE is a kinase inhibitor 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. 3
IBRANCE is a kinase inhibitor 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. 16

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
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
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Letrozole, Palbociclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib
FDA (1) ER positive, HER2-negative, PIK3CA oncogenic variants Invasive Breast Carcinoma Fulvestrant, Inavolisib, Palbociclib
FDA (1) HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Fulvestrant, Inavolisib, Palbociclib
FDA (1) ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Fulvestrant, Inavolisib, Palbociclib
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Exemestane, Palbociclib, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Exemestane, Palbociclib, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Exemestane, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Exemestane, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Letrozole, Palbociclib, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib, Trastuzumab
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Letrozole, Palbociclib, Pertuzumab, Trastuzumab
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib, Pertuzumab, Trastuzumab