Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized palbociclib in combination with fulvestrant for patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, who have also received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

This is written in the approval document as:

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2016-11-09	European Medicines Agency	Indication received approval from the European Commission.