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Novartis breast cancer therapy gets FDA breakthrough designation
January 3, 2018 / 7:00 AM / 14 days ago

Novartis breast cancer therapy gets FDA breakthrough designation

ZURICH (Reuters) - 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.

Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann

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.

Reporting by Michael Shields; Editing by Maria Sheahan

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