Novartis Receives FDA Approval for Kisqali in Early Breast Cancer Adjuvant Setting

Novartis today announced that the FDA has approved Kisqali (ribociclib) in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. In the Phase 3 NATALEE trial, Kisqali plus endocrine therapy demonstrated a statistically significant improvement in invasive disease-free survival compared to endocrine therapy alone. The 3-year iDFS rate was 90.4% for Kisqali plus endocrine therapy versus 87.1% for endocrine therapy alone. This approval expands Kisqali's use into the adjuvant setting for early breast cancer.