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Kisqali® (ribociclib) – Expanded indications and new warning

July 18, 2018 - The FDA announced the approval of Novartis’ Kisqali (ribociclib), for the treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy; and in combination with Faslodex® (fulvestrant) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

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