Regulatory approval

Published by the Food and Drug Administration.

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, 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.

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	Fulvestrant, Palbociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Palbociclib