Drug updated on 3/28/2024
| 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 and a Ki-67 score ≥20% as determined by an FDA approved test.
- 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.
Summary
- Abemaciclib (Verzenio) is indicated in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive early breast cancer at high risk of recurrence and a Ki-67 score ≥20%. It's also used as initial endocrine-based therapy for postmenopausal women and men with advanced or metastatic breast cancer.
- The drug has been associated with an increased risk of venous thromboembolism (VTE), arterial thromboembolism (ATE), and gastrointestinal toxicities such as diarrhea according to pharmacovigilance analysis results from one study.
- In comparison to other cyclin-dependent kinase 4/6 inhibitors like palbociclib, ribociclib, abemaciclib showed higher rates of hematological toxicity primarily neutropenia but lower severe infections rate; it was also linked to more gastrointestinal issues mainly grade 1-2 diarrhea cases.
- A systematic review revealed that adding CDK4/6 inhibitors including Verzenio to endocrine-sensitive or resistant setting significantly improved progression-free survival and objective response rate in metastatic HR+/HER2- breast cancers regardless of menopausal status and site of metastasis despite increasing G3-G4 adverse events.
- Six Systematic Reviews / Meta-Analyses were reviewed which reported dermatologic reactions including alopecia, bullous skin rash among others due to use cyclin-dependent kinase 4/6 inhibitors; these side effects can affect patient's quality life leading potentially discontinuation therapies hence need proper management strategies by health professionals prescribing them.
- One study suggested that administration CDK4/6 inhibitors may provide protective role against aromatase inhibitor-induced musculoskeletal syndrome development which often leads to treatment discontinuation affecting over one-third postmenopausal patients treated AIs thus improving patient's quality life.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Verzenio (abemaciclib) Prescribing Information. | 2021 | 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. | 2021 | Journal of Clinical Oncology |
| Breast cancer, version 3.2020. | 2020 | Journal of the National Comprehensive Cancer Network |
| 5th ESO-ESMO international consensus guidelines for advanced breast cancer. | 2020 | Annals of Oncology |