Background: The inhibition of cyclin-dependent kinases 4 and 6 (CDK4/6) could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2).
CDK4/6 inhibitors are a promising new class of drugs for hormone-receptor-positive breast cancer and have been shown to overcome and delay hormone resistance in advanced breast cancer.
The FDA has approved Kisqali (ribociclib, formerly known as LEE 011) from Novartis, in combination with an aromatase inhibitor, as...
Novartis announced that the European Commission (EC) approved Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal...
This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer who were treatment naïve or had received up to one line of prior endocrine therapy in the advanced setting.
Results from the pivotal Phase III MONALEESA-2 study show LEE011 (ribociclib), from Novartis, plus letrozole significantly extended progression-free survival (PFS)...
Novartis announced that the US FDA has accepted the company's New Drug Application (NDA) for filing and granted Priority Review...
Novartis announced Kisqali (ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial . This...
Novartis announced updated median overall survival (OS) results for Kisqali (ribociclib) in combination with fulvestrant in the first-line subgroup of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
Novartis announced positive topline results from the global MONALEESA-7 trial , the second Phase III trial of Kisqali (ribociclib) in...