INDIANAPOLIS, Oct. 13, 2021
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's (NYSE: LLY) Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), 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 high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation.
Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
The Phase III monarchE trial randomised about 5600 patients with resected early breast cancer to receive two years of Verzenio twice daily plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Both treatment arms continued to receive adjuvant endocrine therapy for up to five to 10 years. The study achieved its primary endpoint of invasive disease-free survival (iDFS) in the entire enrolled population, with Verzenio plus endocrine therapy decreasing the risk of breast cancer recurrence by 28.7% compared to endocrine therapy alone.