Novartis Gains Breakthrough Designation for Breast Cancer Drug

FDA has granted Novartis a breakthrough therapy designation for LEE011 (ribociclib) and its use in combination with letrozole for treating hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The designation was based primarily on positive results from the Phase 3 MONALEESA-2 trial, which met its primary endpoint of clinically meaningful improvement in progression free survival at a pre-planned interim analysis.

LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor, a new class of drugs designed to help slow cancer progression by inhibiting two proteins (cyclin dependent kinase 4 and 6), according to Novartis. “These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly,” it says. Currently, the therapy is being evaluated in combination with additional endocrine agents as part of the MONALEESA clinical trial program.