Novartis (NYSE:NVS) announces that the Phase 3 MONALEESA-7 trial evaluating Kisqali (ribociclib), combined with endocrine therapy, in pre- and postmenopausal women with advanced/metastatic HR+/HER2- breast cancer met the overall survival (OS) endpoint, the first CDK4/6 inhibitor to demonstrate a statistically significant OS effect in these patients.
KISQALI is indicated in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. In pre/perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone agonist. KISQALI® is also indicated in combination with 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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