Regulatory approval

Published by the Health Canada. Approved

IBRANCE (palbociclib) is indicated for the treatment of pre/perimenopausal or postmenopausal women, or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression after prior endocrine therapy.

This is written in the approval document.

Citation

Pfizer Canada ULC. Ibrance (palbociclib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080990.PDF. Revised July 2025. Accessed April 2026.

Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HC (1) ER positive, HER2-negative Invasive Breast Carcinoma Fulvestrant, Palbociclib
HC (1) HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib
HC (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Palbociclib