FDA approves Novartis drug as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor

FDA has approved ribociclib (Kisqali—Novartis) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

FDA has approved ribociclib (Kisqali—Novartis) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The drug, a CDK4/6 inhibitor, was approved based on a first-line Phase III trial that met its primary endpoint early, showing statistically significant improvement in progression-free survival compared with letrozole alone at the first pre-planned interim analysis. The drug was approved under the FDA Breakthrough Therapy designation and Priority Review programs.