Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to palbociclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

This is written in the approval document as:

IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression following endocrine therapy.

Citation

Pfizer. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207103s024lbl.pdf. Revised June 2026. Accessed October 13, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2016-02-19	Food and Drug Administration	Indication received traditional approval.