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.