Novartis' ribociclib receives FDA Breakthrough status in breast cancer

Swiss pharma giant Novartis (NOVN: VX) has received US Food and Drug Administration Breakthrough Therapy designation for LEE011 (ribociclib), in combination with letrozole, for hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor, and its designation is based primarily on positive results of the Phase III Monaleesa-2 trial which met the primary endpoint of clinically meaningful improvement in progression free survival (PFS) at a pre-planned interim analysis.

The trial assessed LEE011 in combination with letrozole in postmenopausal women who had received no prior therapy for their advanced disease.