Novartis breast cancer therapy gets FDA breakthrough designation

ZURICH: Novartis’s Kisqali (ribociclib) has won U.S. Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients, the Swiss drugmaker said on Wednesday.

The designation covers initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.

It was based on results released last month from a Phase III MONALEESA-7 trial demonstrating Kisqali in combination with tamoxifen or an aromatase inhibitor significantly prolonged progression-free survival compared to endocrine therapy alone.