Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.
Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
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