Novartis’s LEE011 gets FDA fast track in advanced breast cancer

ZURICH (Reuters) – The U.S. Food and Drug Administration has granted priority review status for Novartis drug LEE011 (ribociclib) as a 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 Swiss drugmaker said on Tuesday.

The European Medicines Agency (EMA) has also accepted for review the marketing authorization application for LEE011 plus letrozole in the same patient population, it added in a statement.

(Reporting by Michael Shields)