Eli Lilly announces Health Canada’s authorization of Verzenio label expansion

Eli Lilly Canada announces that Health Canada has authorized the label expansion of Verzenio to include the full intention to treat population from the Phase 3 monarchE trial. Verzenio is now 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 based on clinicopathological features, as defined by the presence of four or more positive nodes, or one to three positive nodes and at least one of the following: a tumour of greater than or equal to 5 cm, histological grade 3 disease, or Ki-67 score greater than or equal to 20%. This represents a broader population of patients than what was initially approved by Health Canada for EBC in 2022. This label expansion is supported by four-year follow up data from the Phase 3 monarchE trial which compared the use of 2 years of adjuvant Verzenio in combination with ET vs ET alone in HR+, HER2- node-positive EBC patients at high risk of recurrence based on clinicopathological features. The four-year follow up data indicates that adjuvant Verzenio reduces the risk of disease recurrence and that Verzenio’s benefit is sustained beyond the completion of treatment. Adverse reactions from monarchE were consistent with the known safety profile for Verzenio.