FDA Expands Breast Cancer Indications for Verzenio

The FDA has expanded the approval of Verzenio (abemaciclib) plus endocrine therapy removing the Ki-67 score requirement for patient selection.

The Food and Drug Administration (FDA) has expanded the approval of Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence. 

With the expanded indication, eligible patients for abemaciclib can now be identified as high risk solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least 1 of the following: tumors that are at least 5cm or grade 3). Previously, the treatment required a Ki-67 score of at least 20% for patient selection. 

The approval was based on 4-year data from the phase 3 monarchE trial (ClinicalTrials.gov Identifier: NCT03155997), which evaluated the efficacy and safety of abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6, in adult women and men with HR+, HER2-, node-positive, resected, early breast cancer with clinical and pathological features consistent with a high risk of disease recurrence. Patients were randomly assigned 1:1 to receive 2 years of abemaciclib 150mg twice daily plus physician’s choice of standard endocrine therapy or standard endocrine therapy alone. 

The primary end point was invasive disease-free survival (IDFS), defined as the time from randomization to the first occurrence of 1 of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary nonbreast invasive cancer, or death attributable to any cause. 

At 48 months, the IDFS was 85.5% in the abemaciclib plus endocrine therapy arm vs 78.6% in the endocrine therapy alone arm (317 [12.4%] vs 474 [18.5%], respectively; hazard ratio, 0.653 [95% CI, 0.567-0.753]); this correlated to a 35% risk reduction of recurrence with the addition of abemaciclib to endocrine therapy vs endocrine therapy alone. At the time of analysis, overall survival data were immature. There were no new safety findings, and overall findings were consistent with that observed in previous studies.

“Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer. The magnitude of benefit seen in the 4-year data from the monarchE study reinforces my confidence in adjuvant Verzenio as the standard-of-care for high risk patients in this setting,” said Erika P. Hamilton, MD, medical oncologist, director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, and an investigator on the monarchE clinical trial.

Additionally, the FDA has updated the indication for Verzenio when used in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of HR+, HER2- advanced or metastatic breast cancer to include all adult patients, including pre-/perimenopausal women when used in combination with ovarian suppression. Previously, the indication only included postmenopausal women.


  1. US FDA broadens indication for Verzenio® (abemaciclib) in HR+, HER2-, node-positive, high risk early breast cancer. News release. Eli Lilly and Company. Accessed March 3, 2023. https://www.prnewswire.com/news-releases/us-fda-broadens-indication-for-verzenio-abemaciclib-in-hr-her2–node-positive-high-risk-early-breast-cancer-301762459.html.
  2. Verzenio. Package insert. Eli Lilly and Company; 2023. Accessed March 3, 2023. https://pi.lilly.com/us/verzenio-uspi.pdf.