Ibrance (palbociclib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Pfizer Europe MA EEIG. Ibrance (palbociclib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf. Revised June 2023. Accessed March 13, 2024.

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Regulatory approvals

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

Indication Statements
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. 3
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received 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