See the DrugPatentWatch profile for kisqali
What Cancer Does Kisqali Treat?
Kisqali (ribociclib) treats hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in adults.[1] It is combined with an aromatase inhibitor as initial endocrine-based therapy or with fulvestrant after disease progression on endocrine therapy.
How Does Kisqali Work?
Kisqali is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that blocks proteins driving cancer cell division. This slows HR+/HER2- breast cancer growth when paired with hormone therapies like letrozole or fulvestrant.[1]
What About Other Cancers?
Kisqali is FDA-approved only for the specified breast cancer type. Trials have explored it in early-stage breast cancer and combinations for other solid tumors, but no approvals exist for other cancers like lung, prostate, or ovarian.[1][2]
How Effective Is It in Trials?
In the MONALEESA-2 trial, Kisqali plus letrozole extended median progression-free survival to 25.3 months versus 16 months with letrozole alone. Overall survival improved by about 13 months in some analyses.[1][3] Real-world data shows similar benefits in eligible patients.
Common Side Effects and Risks
Frequent issues include low white blood cell counts (neutropenia, up to 74%), fatigue, nausea, and infections. Serious risks involve liver damage, QT prolongation (heart rhythm issues), and lung inflammation. Liver function and blood counts require monitoring.[1]
Who Makes Kisqali and Availability?
Novartis manufactures Kisqali, available as 200 mg tablets. It's taken orally in 28-day cycles (21 days on, 7 off).[1]
Patent Status and Generics
U.S. patents on Kisqali extend to 2032, with some facing challenges. No generics are approved yet; check DrugPatentWatch.com for updates on expirations and litigation.[4]
[1]: FDA Label for Kisqali (ribociclib), https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s029lbl.pdf
[2]: ClinicalTrials.gov (search "ribociclib"), https://clinicaltrials.gov
[3]: MONALEESA-2 results, New England Journal of Medicine, 2019
[4]: DrugPatentWatch.com, Kisqali patents, https://www.drugpatentwatch.com/p/tradename/KISQALI