Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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