Posted by Michael Wonder on 03 Aug 2016
Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA breakthrough therapy designation as first-line treatment for HR+/HER2- advanced breast cancer
3 August 2016 - Designation underscores the continuing unmet need of the HR+/HER2- advanced breast cancer population and the potential of LEE011 (ribociclib) as an effective new treatment option.
Novartis announced today that the US FDA has granted breakthrough therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of 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.
The Breakthrough Therapy designation is based primarily on positive results of the Phase III MONALEESA-2 trial of LEE011 in combination with letrozole in postmenopausal women who had received no prior therapy for their advanced disease[1]. The MONALEESA-2 trial met the primary endpoint of clinically meaningful improvement in progression free survival (PFS) at a pre-planned interim analysis. Results of this study will be presented at an upcoming medical congress and will form the basis of regulatory discussions in the US, Europe and other countries for use in this indication.
