Posted by Michael Wonder on 24 Aug 2017
Novartis Kisqali (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor
24 August 2017 - Approval is based on pivotal MONALEESA-2 trial, which showed Kisqali plus letrozole reduced risk of disease progression or death by 43% versus letrozole alone.
Novartis announced that the European Commission approved Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.
Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival at interim analysis.
