The FDA accepted the new drug application (NDA) for filing and granted priority review for LEE011 (ribociclib) as first-line treatment of postmenopausal 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 percent (HR = 0.556, 95% CI: 0.429-0.720; P = 0.00000329) over letrozole alone, significantly extending progression-free survival across all patient subgroups.
FDA Priority Review designation requires the agency to take action on an application within 6 months of its filing date compared to 10 months under standard review. FDA grants Priority Review to applications for new drug candidates that treat serious conditions, such as advanced breast cancer for which there is currently no cure, and if approved, would provide a significant improvement in treatment safety or efficacy.