Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to palbociclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on PALOMA-2 (NCT01740427), an international, randomized, double-blind, parallel-group, multicenter study of palbociclib plus letrozole versus placebo plus letrozole.

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 an aromatase inhibitor as initial endocrine-based 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	Letrozole, Palbociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Palbociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Palbociclib