Results from a second Phase 3 clinical, MONALEESA-3, evaluating Novartis’ (NVS +0.6%) CDK4/6 inhibitor Kisqali (ribociclib), combined with fulvestrant [AstraZeneca’s Faslodex], in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced/metastatic breast cancer showed a statistically significant improvement in overall survival (OS) compared to fulvestrant alone in first-line and second-line settings.
Complete results will be presented at an upcoming medical conference and submitted to global regulatory authorities.
Another Phase 3, MONALEESA-7, also met the OS endpoint.
The FDA first approved Kisqali in March 2017.
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