Eli Lilly and Company has received FDA approval from the US FDA (Food and Drug Administration) for the first and only CDK4/6 inhibitor for a specific group of people with Breast Cancer. Verzenio, abemaciclib, aims to treat adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early and high-risk breast cancer (EBC), as well as patients with a Ki-67 score of ≥20% as defined by an FDA-approved test. The approval is based on the randomized, open-label, two cohort, multicenter, Verzenio Phase 3 monarchE trial which studied adult women and men with HR+ HER2-, node-positive, resected EBC with a high risk of recurrence. The FDA approval for Verzenio expands the drugs usage as the drug is already approved to treat patients with certain types of HR+ HER2- advanced or metastatic breast cancer.
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