Novartis breast cancer therapy gets FDA nod

January 4, 2018

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

The designation covers initial endocrine-based treatment of pre- or premenopausal 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.


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