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.

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.
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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies