Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized palbociclib in combination with an aromatase inhibitor for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This indication is based on a randomized phase 3 study, PALOMA-2, that evaluated letrozole in combination with either palbociclib or placebo. 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 an aromatase inhibitor.

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.

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