FDA Approves Novartis Breast Cancer Therapy

FDA has approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is a CDK4/6 inhibitor, and it was approved based on a first-line Phase 3 trial that met its primary endpoint early — demonstrating statistically significant improvement in progression-free survival compared to letrozole alone at the first pre-planned interim analysis. The trial, which enrolled 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer, showed that Kisqali plus an aromatase inhibitor, letrozole, reduced the risk of progression or death by 44% over letrozole alone, according to the company.