Novartis pill gets U.S. breakthrough designation in breast cancer

By Reuters Staff

ZURICH (Reuters) - Novartis AG breast cancer pill LEE011 has won breakthrough therapy designation from U.S. regulators as a first-line treatment for a form of advanced breast cancer, the Swiss drugmaker said on Wednesday.

The Food and Drug Administration granted the designation to LEE011 in combination with letrozole for treating hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

LEE011 (ribociclib) is a selective cyclin dependent kinase (CDK4/6) inhibitor.

Clinical trial testing of the pill was stopped early because of good results.

"The Breakthrough Therapy designation is based primarily on positive results of the Phase III MONALEESA-2 trial of LEE011 in combination with letrozole in postmenopausal women who had received no prior therapy for their advanced disease," Novartis explains in a statement.

"The MONALEESA-2 trial met the primary endpoint of clinically meaningful improvement in progression free survival (PFS) at a pre-planned interim analysis. Results of this study will be presented at an upcoming medical congress and will form the basis of regulatory discussions in the US, Europe and other countries for use in this indication."

The Breakthrough designation aims to expedite the development and review of potential new medicines that treat serious or life-threatening conditions.