Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Anastrozole, Ribociclib
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Ribociclib
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Ribociclib
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Letrozole, Ribociclib
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Ribociclib
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Ribociclib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-12-10	Food and Drug Administration	Indication received traditional approval.