Ribociclib Granted Breakthrough Designation for Advanced Breast Cancer

The FDA has granted breakthrough therapy designation to Novartis’s ribociclib (LEE011), which is seeking an indication for use in combination with letrozole to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

LEE011 is a selective cyclin-dependent kinase (CDK) inhibitor that can potentially slow cancer progression by inhibiting 2 proteins: CDK4 and 6. The drug’s breakthrough therapy designation was mostly based on positive results from the phase 3 MONALEESA-2 trial, which looked at how LEE011 in combination with letrozole could treat postmenopausal women with HR+/HER2- advanced breast cancer who had received no prior therapy for their condition.

The trial met its primary endpoint of clinical improvement in progression-free survival at a preplanned interim analysis, and overall survival data continue to be assessed. “Despite advancements in treatment, an estimated 40,000 individuals in the United States die each year from advanced breast cancer,” said Alessandro Riva, MD, Global Head, Oncology Development and Medical Affairs at Novartis Oncology, in a press release.

“This designation shows the potential of LEE011, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with HR+/HER2- advanced breast cancer as quickly as possible.”

LEE01 was developed by Novartis Institutes for Biomedical Research under a research collaboration with Astex Pharmaceuticals.