Novartis' ribociclib receives FDA Priority Review for advanced breast cancer
The US Food and Drug Administration has accepted Swiss pharma major Novartis’ (NOVN: VX) New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib) in advanced breast cancer.
In the review, the drug’s suitability is being investigated as a 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 study, which was presented at the European Society for Medical Oncology (ESMO) 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% over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups.
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