Summary

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• 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.