Regulatory approval
Published by the Health Canada. Approved
Health Canada approved palbociclib in combination with fulvestrant for the treatment of pre/perimenopausal or postmenopausal women, or men with HR-positive, HER2-negative locally advanced or metastatic breast cancer with disease progression after prior endocrine therapy.
This is written in the approval document as:
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.
Citation
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 |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |