Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 50 mg, 100 mg, 150 mg, 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence
- Indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- Indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
- Indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Latest News
Summary
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- Abemaciclib combined with endocrine therapy (ET) significantly improved progression-free survival (PFS) and overall survival (OS) in hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer, achieving 3.059 progression-free life years (PFLYs) and 6.275 life years (LYs).
- Abemaciclib + ET showed improved objective response rate (ORR) and disease control rate (DCR) compared to ET alone, demonstrating superior therapeutic effects.
- In comparisons with other cyclin-dependent kinase (CDK)4/6 inhibitors, Abemaciclib + ET had significantly better PFS than Ribociclib, Palbociclib, and Dalpiciclib combinations, while Ribociclib + ET yielded the best OS outcomes, followed by Abemaciclib + ET.
- Abemaciclib + ET ranked highly in reducing the risk of major adverse cardiovascular events (MACE) and showed significantly lower rates of grade ≥3 neutropenia among CDK4/6 inhibitors.
- Abemaciclib combined with ET was associated with common adverse events (AEs), including diarrhea, fatigue, and gastrointestinal (GI) toxicity. Grade ≥3 AEs were significant, particularly diarrhea and neutropenia.
- Abemaciclib had a lower risk of MACE compared to other CDK4/6 inhibitors but was linked to more GI toxicity (diarrhea) compared to Palbociclib and Ribociclib.
- Specific adverse events included the highest incidence of diarrhea with Abemaciclib, more neutropenia with Palbociclib and Ribociclib, and greater hepatotoxicity with Ribociclib.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Verzenio (abemaciclib) Prescribing Information. | 2023 | Lilly USA, LLC., Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Guideline Update | 2022 | Journal of Clinical Oncology |
| Abemaciclib With Endocrine Therapy in the Treatment of High-Risk Early Breast Cancer: ASCO Optimal Adjuvant Chemotherapy and Targeted Therapy Guideline Rapid Recommendation Update. | 2022 | Journal of Clinical Oncology |
| Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology. | 2020 | Journal of the National Comprehensive Cancer Network |
| 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) | 2020 | Annals of Oncology |