Posted by Michael Wonder on 01 Nov 2016
Novartis LEE011 (ribociclib) granted FDA priority review for first-line treatment of HR+/HER2- advanced breast cancer
1 November 2016 - A marketing authorization application for LEE011 plus letrozole has also been accepted for review by the EMA.
Novartis announced today that the US FDA accepted the company's New Drug Application (NDA) for filing and granted priority review for LEE011 (ribociclib) as first-line treatment of post-menopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole.
The NDA is based on a comprehensive clinical package, including results of the Phase III MONALEESA-2 trial. The trial, which was presented at the European Society for Medical Oncology 2016 Congress and published simultaneously in the New England Journal of Medicine, showed LEE011 plus letrozole reduced the risk of progression or death by 44% (HR = 0.556, 95% CI: 0.429-0.720; P = 0.00000329) over letrozole alone, significantly extending progression-free survival across all patient sub-groups.
