Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer following induction treatment. This indication is based on PATINA (NCT02947685), a randomized, open-label trial in which endocrine therapy consisted of either fulvestrant or aromatase inhibitors (anastrozole, letrozole, or exemestane).

This is written in the approval document as:

IBRANCE is a kinase inhibitor indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Anastrozole, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Exemestane, Palbociclib, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Exemestane, Palbociclib, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Exemestane, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Exemestane, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Letrozole, Palbociclib, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib, Trastuzumab
FDA (2) ER positive, HER2-positive Invasive Breast Carcinoma Letrozole, Palbociclib, Pertuzumab, Trastuzumab
FDA (2) HER2-positive, PR positive Invasive Breast Carcinoma Letrozole, Palbociclib, Pertuzumab, Trastuzumab

Contributions

Date Contributor Description
2026-10-13 Van Allen lab Initial curation of this indication into moalmanac-db.
2026-06-24 Food and Drug Administration Indication received traditional approval.