Posted by Michael Wonder on 13 Mar 2017
Novartis Kisqali (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor
13 March 2017 - Approved based on a first-line Phase III trial that met its primary endpoint of progression-free survival at interim analysis due to superior efficacy compared to letrozole alone.
The US FDA has approved Kisqali (ribociclib, formerly known as LEE011) 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 approved based on a first-line Phase III 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. Kisqali was reviewed and approved under the FDA breakthrough therapy designation and priority review programs.
