Regulatory approval
Published by the Health Canada. Approved
Health Canada approved abemaciclib in combination with an aromatase inhibitor, in combination with fulvestrant, or as a single agent for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women as initial endocrine-based therapy, in women with disease progression following endocrine therapy, or in women with disease progression following endocrine therapy and at least two prior chemotherapy regimens.
This is written in the approval document as:
VERZENIO (abemaciclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy, in combination with fulvestrant in women with disease progression following endocrine therapy, or as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens.
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 | |
| HC (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib | |
| HC (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib | |
| HC (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Exemestane | |
| HC (1) | ER positive, HER2-negative | Invasive Breast Carcinoma | Abemaciclib, Exemestane | |
| HC (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Abemaciclib, Exemestane |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |