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Novartis breast cancer therapy gets FDA breakthrough

REUTERS
Published : Jan 3, 2018, 1:44 pm IST
Updated : Jan 3, 2018, 1:47 pm IST

Designation covers initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive.

Novartis’s Kisqali (ribociclib) has won U.S. Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients. (Photo: Pixabay)
 Novartis’s Kisqali (ribociclib) has won U.S. Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients. (Photo: Pixabay)

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.

Tags: novartis, breast cancer, fda, health and well being