FDA Approves Novartis’s Breast Cancer Drug for Breakthrough Designation

FDA has granted Novartis breakthrough therapy designation for its metastatic breast cancer candidate LEE011.

The designation for the drug candidate, which is a selective cyclin dependent kinase inhibitor, is for its use in combination with letrozole in treating hormone receptors for breast cancer patients.

The FDA’s decision was based on a positive Phase 3 trial that met its primary endpoint of clinically meaningful improvement in progression free survival.