Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to ribociclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on MONALEESA-2 (NCT01958021) and MONALEESA-7 (NCT02278120), where either anastrozole or letrozole were chosen for aromatase inhibiton.
This is written in the approval document as:
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.
Citation
Novartis Pharmaceuticals Corporation. Kisqali (ribociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf. Revised September 2024. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ER positive, HER2-negative | Invasive Breast Carcinoma | Anastrozole, Ribociclib | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative | Invasive Breast Carcinoma | Letrozole, Ribociclib | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Letrozole, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Letrozole, Ribociclib |