FDA Grants Fast Track to Novartis Breast Cancer Drug

The FDA has awarded fast-track review status to Novartis's medication ribociclib in first-line treatment of postmenopausal women with advanced breast cancer, as the Swiss company seeks to challenge Pfizer's Ibrance.

The decision is based on data showing patients with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer who took ribociclib with letrozole were 44 percent less likely to have their disease progress or to die versus those on letrozole alone.