Abemaciclib

(Verzenio®)

Abemaciclib

Drug updated on 5/17/2024

Dosage FormTablet (oral; 50 mg, 100 mg, 150 mg, 200 mg)
Drug ClassKinase 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

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Abemaciclib (Verzenio) is approved 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 a high risk of recurrence. It is also used as an initial endocrine-based therapy for postmenopausal women and men with advanced or metastatic breast cancer. Additionally, it can be used in combination with fulvestrant for adults whose disease has progressed following endocrine therapy.
  • Nine systematic reviews/meta-analyses provided a comprehensive evaluation of Verzenio's safety and effectiveness compared to other drugs within its class.
  • Verzenio demonstrates a substantial improvement in invasive disease-free survival among patients with HR-positive, HER2-negative early breast cancer at high risk of recurrence, highlighting its capacity to extend progression-free survival rates.
  • In terms of a safety profile comparison against CDK4/6 inhibitors counterparts like palbociclib and ribociclib, abemaciclib shows an increase in gastrointestinal toxicities, primarily diarrhea, but presents a distinct advantage concerning the incidence of grade 3 neutropenia, showcasing a significantly lower occurrence suggesting a preferable safety profile for susceptible patients.
  • Compared against PI3K/AKT/mTOR inhibitors, data suggest that CDK4/6 inhibitors, including abemaciclib, might offer better efficacy, particularly in delaying disease progression, while having comparable overall survival rates, making them a preferable choice for hormone receptor-positive HER2-negative metastatic breast cancer patients.
  • Subgroup considerations reveal a potential protective role against aromatase inhibitor-associated musculoskeletal syndrome, influencing treatment choices especially among postmenopausal women; however, the pre-treated patient subgroup showed a more pronounced risk towards grade 3 - 4 diarrhea and neutropenia, impacting treatment consideration based on prior exposure history.

Product Monograph / Prescribing Information

Document TitleYearSource
Verzenio (abemaciclib) Prescribing Information.2023Lilly USA, LLC., Indianapolis, IN

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
Abemaciclib in combination with endocrine therapy for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer: an evidence review group perspective of a nice single technology appraisal. 2023PharmacoEconomics
Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors: a real-world pharmacovigilance study and a systematic review.2023Expert Opinion on Drug Safety
CDK4/6 inhibitors versus PI3K/AKT/mTOR inhibitors in women with hormone receptor-positive, HER2-negative metastatic breast cancer: an updated systematic review and network meta-analysis of 28 randomized controlled trials. 2022Frontiers in Oncology
Emerging skin toxicities in patients with breast cancer treated with new cyclin-dependent kinase 4/6 inhibitors: a systematic review. 2021Drug Safety
CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis. 2021Expert Review of Anticancer Therapy
CDK4/6 inhibitors as adjuvant treatment for hormone receptor-positive, HER2-negative early breast cancer: a systematic review and meta-analysis. 2021EMSO Open
Aromatase and CDK4/6 inhibitor-induced musculoskeletal symptoms: a systematic review.2021Cancers
Cyclin dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor positive breast cancer patients: a systematic review and meta analysis of randomized clinical trials. 2020Cancer Treatment and Research Communications

Clinical Practice Guidelines