Regulatory approval
Published by the Health Canada. Approved
Health Canada approved ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence. This indication is based on NATALEE (LEE011 O12301C) was a randomized (1:1), open-label, multicenter study, where participants received goserelin and either letrozole or anastrozole, in addition to ribociclib.
This is written in the approval document as:
KISQALI (ribociclib tablets) is indicated, in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence.
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 | Anastrozole, Goserelin, Ribociclib | |
| HC (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Goserelin, Ribociclib | |
| HC (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Goserelin, Ribociclib | |
| HC (1) | ER positive, HER2-negative | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib | |
| HC (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib | |
| HC (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |