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Novartis at ESMO: Kisqali plus fulvestrant achieved statistically significant overall survival benefit vs. fulvestrant alone in postmenopausal women

Novartis will present results from its trial designated Mnaleesa-3, which showed that ribociclib branded as Kisqali has achieved statistically significant improvement in overall survival (OS), which is – according to Novartis – the only CDK4/6 inhibitor to demonstrate positive overall survival in two pivotal Phase III trials — consistently demonstrating approximately 30% reduction in the risk of death.

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EC approves Novartis’s metastatic breast cancer drug

European Commission (EC) approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

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FDA OK’s Novartis’s breast cancer drug

The US Food and Drug Administration (FDA) has approved Novartis’s Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

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