Kisqali FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2024.
FDA Approved: Yes (First approved March 13, 2017)
Brand name: Kisqali
Generic name: ribociclib
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer
Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 used for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
- Kisqali is 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.
- for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:
• an aromatase inhibitor as initial endocrine-based therapy;
• or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
Development timeline for Kisqali
Further information
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