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Efficacy, safety and toxicity management of adjuvant abemaciclib in early stage HR+/HER2- high-risk breast cancer

Introduction: The majority of the over 250,000 new cases of invasive breast cancer diagnosed in the United States is driven by hormone receptor signaling (HR+). Since 2015, cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) have become the standard in combination with endocrine therapy (ET) for patients facing metastatic disease.

Areas covered: There are now three approved agents in the metastatic setting; abemaciclib, ribociclib, and palbociclib. Due to the almost doubling of progression free survival (PFS) and improvement in overall survival (OS) in the metastatic setting, studies were conducted to examine the benefit of adding CDK4/6i in the adjuvant setting for those patients at high risk for recurrence. Despite negative results of PALLAS (palbociclib) in this setting, monarchE (abemaciclib) showed an improvement in invasive disease-free survival (IDFS) and distant recurrence free survival (DRFS) at the 3 year time point for patients with high risk tumor characteristics leading to its approval. Herein, we discuss the data, the population studied and the population in which abemaciclib is approved as well as safety, tolerability, and dose reductions for practical management of these patients.

Expert opinion: Abemaciclib is appropriate and beneficial for those patients with high-risk, node-positive, hormonally-driven breast cancer.

Related Products

Cat.No. Product Name Information
S7158 Abemaciclib mesylate Abemaciclib mesylate is a potent and selective inhibitor of CDK4 and CDK6 with IC50 of 2 nM and 10 nM in cell-free assays, respectively. Phase 3.

Related Targets

CDK