Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that HER2-negative and PR positive status confers therapeutic sensitivity to Abemaciclib, Tamoxifen in patients with Invasive Breast Carcinoma.
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 statement is based on a regulatory approval from the Health Canada:
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
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 |