FDA Expands Approval of Eli Lilly’s Verzenio for High-Risk Early Breast Cancer

The FDA has granted expanded approval to Eli Lilly’s Verzenio (abemaciclib) with endocrine therapy (tamoxifen or an aromatase inhibitor) as adjuvant treatment in adult patients with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.

The expanded approval removes the requirement of high-risk patients needing a Ki-67 (a nuclear protein that is a predictive indicator of cancer) score equal to or greater than 20 percent.

The agency decision was supported by efficacy results from a clinical trial, with the combination treatment showing improved invasive disease-free survival, which was 85.5 percent at 48 months.

Verzenio first received FDA approval in 2017.