LEE 011 (ribociclib) + letrozole filed with FDA and EMA for HR+/HER2- metastatic breast cancer- Novartis

Novartis announced that the US FDA has accepted the company's New Drug Application (NDA) for filing and granted Priority Review for LEE 011 (ribociclib) as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole.

The NDA is based on a comprehensive clinical package, including results of the Phase III MONALEESA-2 trial. The trial, which was presented at the European Society for Medical Oncology (ESMO) 2016 Congress and published simultaneously in the New England Journal of Medicine, showed LEE 011 plus letrozole reduced the risk of progression or death by 44% (HR = 0.556, 95% CI: 0.429-0.720; P = 0.00000329) over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups. The company also announced that the EMA has accepted for review the marketing authorization application for LEE 011 plus letrozole in the same patient population.

Comment: Novartis is continuing to assess LEE011 through the robust MONALEESA clinical trial program, which includes MONALEESA-2, MONALEESA-3, and MONALEESA-7. These trials are evaluating LEE 011 in multiple endocrine therapy combinations across a broad range of patients, including men and premenopausal women.