Regulatory approval
Published by the Health Canada. Approved
Health Canada approved abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features.
This is written in the approval document as:
VERZENIO (abemaciclib) is indicated in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features.
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 | Abemaciclib, Tamoxifen | |
| HC (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Tamoxifen | |
| HC (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Tamoxifen |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-04-10 | Van Allen lab | Added propositions and statements for approval of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for patients with HR+, HER2- breast cancer. Additional propositions are for combinations with letrozole, anastrozole, or exemestane per endocrine offerings within monarchE (NCT03155997). |
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |