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Find Clinical Drug Pipeline Developments & Deals for Ribociclib
Kisqali-Generic (ribociclib) is a cyclin-dependent kinase 4/6 inhibitor, which is indicated for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Under the collaboration, Novartis will increase the size of the ongoing Phase 1/2 study testing OP-1250 (palazestrant), an orally-available small molecule with dual activity as both a complete ER antagonist and a selective ER degrader, in combination with ribociclib.
Kisqali® (ribociclib) is the only USFDA approved category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.
Kisqali (ribociclib) is the only CDK4/6 inhibitor with proven overall survival benefit across all three pivotal Phase III advanced breast cancer trials and is recognized as the only CDK4/6i with overall survival benefit in first-line HR+/HER2- advanced breast cancer.
Kisqali (ribociclib) is a unique CDK4/6 inhibitor, consistently demonstrating statistically significant OS benefit while maintaining or improving quality of life across three Phase III trials, regardless of patient or disease characteristics.
Overall survival results from pooled exploratory analysis of MONALEESA trials in patients with aggressive HR+/HER2- advanced breast cancer treated with Kisqali® (ribociclib).
In new exploratory analysis of data from MONALEESA-2 study, Kisqali (ribociclib) plus letrozole maintained an OS benefit for postmenopausal patients with metastatic breast cancer treated in first-line, including for those patients who required dose modification of Kisqali.
Latest in HR+/HER2- metastatic breast cancer, including data on CDK recycling with Kisqali® plus endocrine therapy, further MONALEESA-2 quality of life and overall survival analyses, and a new biomarker analysis of Piqray® plus fulvestrant.
With further follow-up of MONALEESA-3, Kisqali (ribociclib) plus fulvestrant achieved a median overall survival (OS) of more than five-and-a-half years (67.6 months) in the first-line (1L) setting for postmenopausal women living with HR+/HER2- aBC.
MONALEESA-2 results show a statistically significant more than one-year increase in survival for women with HR+/HER2- postmenopausal aBC when using Kisqali plus letrozole compared to letrozole alone as first-line therapy.