Drug updated on 6/24/2024
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
- Ribociclib (Kisqali) is recommended for the management of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. It is effective when used with an aromatase inhibitor as initial endocrine-based therapy or in combination with fulvestrant after disease progression on endocrine therapy.
- Ten systematic reviews/meta-analyses provided insights into the drug's safety and effectiveness in comparison to others such as abemaciclib and palbociclib.
- The comparative efficacy among ribociclib, abemaciclib, and palbociclib did not show statistical significance across the studies reviewed. Nonetheless, evidence supports the addition of CDK4/6 inhibitors like ribociclib to endocrine therapy to significantly enhance therapeutic efficacy.
- Regarding adverse events, ribociclib and abemaciclib exhibited greater gastrointestinal toxicity than palbociclib. Palbociclib more frequently resulted in neutropenia but demonstrated a lower risk of severe infections. Ribociclib was associated with less severe transaminitis and neutropenia than abemaciclib.
- Subgroup analysis indicated that the concurrent use of proton pump inhibitors might lead to worse outcomes for patients using palbociclib, but this was not significantly the case for ribociclib. This implies possible considerations for its use in specific patient subgroups. Furthermore, it showed a favorable profile in comparisons of overall survival rates, suggesting that individual patient factors could play a role in the decision-making process regarding its use.
- In the context of neoadjuvant therapies involving CDK4/6 inhibitors combined with endocrine therapies as opposed to monotherapies or standard chemotherapy treatments; the combination therapies exhibited increased efficacy, albeit at higher toxicity levels. However, they still maintained better safety profiles than neoadjuvant chemotherapy alone.
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 |