Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ER positive, HER2-negative, and PR positive status confers therapeutic sensitivity to Fulvestrant, Ribociclib in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to ribociclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as either an initial endocrine-based therapy or following disease progression on endocrine therapy.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. Novartis Pharmaceuticals Corporation. Kisqali (ribociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf. Revised December 2021. Accessed October 6, 2026.

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.