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 for the adjuvant treatment of adult patients 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. This indication is based on NATALEE (NCT03701334) 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 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.

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, 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