Summary:
- The U.S. Food and Drug Administration (FDA) has expanded the approval of Novartis' breast cancer drug Kisqali (ribociclib) to include premenopausal and perimenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
- This expanded approval allows Kisqali to be used in combination with an aromatase inhibitor as initial endocrine-based therapy in this patient population.
- The expansion is based on positive results from the MONALEESA-7 trial, which showed that the Kisqali-aromatase inhibitor combination significantly improved progression-free survival compared to an aromatase inhibitor alone in premenopausal and perimenopausal women with advanced breast cancer.