Ibrance (palbociclib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Pfizer Canada ULC. Ibrance (palbociclib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080011.PDF. Revised March 2025. Accessed June 2025.

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Regulatory approvals

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

Indication Statements
IBRANCE (palbociclib) is indicated for the treatment of pre/perimenopausal or postmenopausal women, or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. 3
IBRANCE (palbociclib) is indicated for the treatment of pre/perimenopausal or postmenopausal women, or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression after prior endocrine therapy. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Letrozole, Palbociclib
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Fulvestrant, Palbociclib
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib