27 November 2024 - Approval is based on Phase 3 NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy demonstrated clinically meaningful invasive disease-free survival benefit in patients with stage II or III HR positive/HER2 negative early breast cancer, consistent across all sub-groups.
Novartis announced today that the European Commission has approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer at high risk of recurrence.