Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 200 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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.
- Indicated 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.
Latest News
Summary
- Kisqali (ribociclib) is indicated 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 and 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.
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- CDK4/6 inhibitors (ribociclib, palbociclib, and abemaciclib) combined with endocrine therapy significantly improved progression-free survival (PFS) and overall survival (OS) in patients with HR+/HER2- advanced breast cancer compared to endocrine therapy alone. Specific combinations showed varied outcomes: abemaciclib + letrozole had the most favorable PFS, while ribociclib + fulvestrant yielded the best OS.
- All treatment combinations involving CDK4/6 inhibitors significantly reduced PFS hazard risks compared to monotherapy with aromatase inhibitors or fulvestrant. There were no statistically significant differences in OS among the three CDK4/6 inhibitors.
- Subgroup analyses were conducted in some studies, particularly focusing on postmenopausal women with HR+/HER2- advanced breast cancer. However, specific findings for different subgroups were generally not detailed in the provided studies.
- Across the studies, CDK4/6 inhibitors, when combined with fulvestrant, consistently showed significant improvements in both PFS and OS compared to fulvestrant alone, with no significant heterogeneity observed among the trials.
- Ribociclib and abemaciclib were associated with higher gastrointestinal toxicity (grade 1-2 vomiting) and grade 3-4 diarrhea, respectively, compared to palbociclib, which showed higher rates of neutropenia and lower GI toxicity.
- Severe adverse events (AEs) were most commonly observed with combinations involving palbociclib + AI, abemaciclib + AI or fulvestrant, and ribociclib + AI; hematological toxicity was notably high with palbociclib and ribociclib, while abemaciclib had a higher incidence of gastrointestinal toxicity.
- The combination of CDK4/6 inhibitors with fulvestrant did not significantly increase serious AEs compared to fulvestrant alone, although specific CDK4/6 inhibitors demonstrated variable safety profiles regarding diarrhea, fatigue, neutropenia, and hepatotoxicity.
- There is no population or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Kisqali (Ribociclib) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. | 2024 | Annals of Oncology |
Breast Cancer. Version 3. 2020. | 2020 | Journal of the National Comprehensive Cancer Network |