Ribociclib

(Kisqali®)

Ribociclib

Drug updated on 11/13/2023

Dosage FormTablet (oral; 200 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.
  • For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.

Product Monograph / Prescribing Information

Document TitleYearSource
Kisqali (Ribociclib) Prescribing Information.2022Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer-A Systematic Review of Randomized Phase II and III Clinical Trials.2023Biomolecules
The likelihood of being helped or harmed as a patient-centred tool to assess cyclin dependent kinase 4/6 inhibitors clinical impact and safety in metastatic breast cancer: a systematic review and sensitivity-analysis.2023EClinicalMedicine
Second-line Endocrine Therapy of Hormone Receptor-positive/HER2- negative Advanced Breast Cancer: A Systematic Review and Network Meta-analysis. 2023Current cancer drug targets.
Emerging skin toxicities in patients with breast cancer treated with new cyclin‑dependent kinase 4/6 inhibitors: a systematic review. 2021Drug Safety
Efficacy and safety of CDK4/6 and PI3K/AKT/mTOR inhibitors as second-line treatment in postmenopausal patients with hormone receptor-positive, HER-2-negative metastatic breast cancer: a network meta-analysis. 2021Expert Opinion on Drug Safety
Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy. 2021NICE
Neoadjuvant therapy of cyclin-dependent kinase 4/6 inhibitors combined with endocrine therapy in HR+/HER2− breast cancer: a systematic review and meta-analysis.2021Oncology Research and Treatment
Australian public assessment report for ribociclib.2020Australian Government: Department of Health
Final clinical guidance report: ribociclib (Kisqali) plus fulvestrant for advanced or metastatic breast cancer. 2020CADTH
CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis. 2020Expert Review of Anticancer Therapy
Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis.2019The Lancet. Oncology
Comparative efficacy of palbociclib, ribociclib and abemaciclib for ER+ metastatic breast cancer: an adjusted indirect analysis of randomized controlled trials.2019Breast Cancer Research and Treatment
CDK4/6 inhibitors in combination with hormone therapy for HR+/HER2− advanced breast cancer: a systematic review and meta-analysis of randomized controlled trials. 2018Clinical Breast Cancer
Assessment report: Kisqali. 2018EMA
Final clinical guidance report: ribociclib (Kisqali) for metastatic breast cancer. 2018CADTH
Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper. 2018Therapeutic Advances in Medical Oncology

Clinical Practice Guidelines

Document TitleYearSource
Breast Cancer, version 3.2020. 2020Journal of the National Comprehensive Cancer Network