U.S. FDA Broadens Indication for Verzenio® (abemaciclib)
Friday, March 03, 2023
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumour size, and tumour grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumours that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.
This expanded approval allows to bring Verzenio to many more women and men with HR+, HER2-, high risk early breast cancer in the curative setting – before patients experience recurrence, potentially to incurable metastatic disease. The initial adjuvant approval for Verzenio changed the treatment paradigm, and the strength of the monarchE results supporting this approval underscores the role this differentiated CDK4/6 inhibitor in reducing the risk of recurrence in early breast cancer.
Verzenio® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a nonchemotherapy oral tablet. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells so that they may eventually die (based on preclinical studies).
