FDA grants priority review for Novartis’ first-line treatment of HR+/HER2- advanced breast cancer
Posted: 7 November 2016 | | No comments yet
The US Food and Drug Administration (FDA) accepted Novartis’ new drug application (NDA) for filing and granted priority review for LEE011 (ribociclib)…
The US Food and Drug Administration (FDA) accepted Novartis’ new drug application (NDA) for filing and granted priority review for LEE011 (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, presented as ESMO 2016, showed LEE011 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 authorisation application for LEE011 plus letrozole in the same patient population.
“These regulatory milestones, along with the FDA breakthrough therapy designation granted in August, underscore the need for new treatment options for women living with HR+/HER2- advanced breast cancer,” said Bruno Strigini, CEO, Novartis Oncology.
“Priority Review allows a shorter review period compared with FDA standard review in the US, helping us to potentially bring LEE011 plus letrozole to patients more quickly. We also are working diligently with the EMA and other Health Authorities to bring this treatment to patients around the world as fast as possible.”