Novartis Receives FDA Approval for Kisqali in Premenopausal Breast Cancer

Novartis today announced that the FDA has approved Kisqali (ribociclib) in combination with endocrine therapy for premenopausal or perimenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. In the Phase 3 MONALEESA-7 trial, Kisqali plus endocrine therapy demonstrated a statistically significant improvement in overall survival compared to placebo plus endocrine therapy. The median OS was 58.7 months for Kisqali plus endocrine therapy versus 48.0 months for placebo plus endocrine therapy. This approval expands Kisqali's use to include premenopausal women with HR+ HER2- advanced breast cancer.