Kisqali (ribociclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	6
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 fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.	3
KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.	6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib