Pharmaceuticals, Biotechnology and Life Sciences
The New England Journal of Medicine (NEJM) published data showing the Phase III MONALEESA-2 trial for NovartIs’s Kisqali (ribociclib) plus letrozole demonstrated a statistically significant improvement in overall survival.
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.
Novartis on Sunday announced positive results from the third Phase III trial of Kisqali in advanced or metastatic breast cancer.
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.
Diplomat Pharmacy will distribute Novartis’s newly approved breast cancer drug Kisqali (ribociclib) as a first-line treatment for postmenopausal women with a serious form of the disease.
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.