Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ER positive, HER2-negative, and PR positive status confers therapeutic sensitivity to Fulvestrant, Palbociclib in patients with Invasive Breast Carcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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, Inc. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf. Revised September 2023. Accessed October 30, 2024. Pfizer, Inc. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf. Revised February 2016. Accessed October 6, 2026.

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.