FDA Approves Expanded Indication for Adjuvant Abemaciclib in HR+/HER2- Early Breast Cancer


The expansion was based on 4-year data from the monarchE study.

The FDA has approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for adjuvant treatment of adults with HR+/HER2-, node-positive, early breast cancer with a high risk of recurrence, according to a press release from Eli Lilly.1

The expanded adjuvant indication removes the Ki-67 score requirement for patient selection; following the approval, eligible patients can be identified based solely on nodal status, tumor size, and tumor grade.

“Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer,” said Erika P. Hamilton, MD, medical oncologist, director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, and clinical trial investigator. “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.”

The phase 3 monarchE study (NCT03155997) enrolled a cohort of 5637 adults who met study inclusion criteria into 1 of 2 cohorts, receiving either abemaciclib or a standard adjuvant endocrine therapy. At 4 years, investigators found that 85.5% of patients were recurrence-free with abemaciclib plus endocrine therapy, compared with endocrine therapy alone (78.6%; absolute difference, 6.9%). Additionally, those in the abemaciclib plus endocrine therapy group demonstrated a “deepened benefit in invasive disease-free survival beyond the 2-year treatment course” with adjuvant abemaciclib, and the absolute difference in invasive disease-free survival increased over time.

At 2 and 3 years, the absolute between-group treatment differences were 3.1% and 5%, respectively, and the addition of abemaciclib to endocrine therapy reduced recurrence risk by 35% (hazard ratio, 0.653; 95% CI, 0.567-0.753).

Additionally, no new safety findings were noted; overall results were, the researchers noted, consistent with the “well-established safety profile” for abemaciclib.

“This expanded approval will allow us to bring Verzenio to many more women and men with HR+, HER2-, high-risk early breast cancer in the curative setting—before patients experience recurrence, potentially to incurable metastatic disease,” said Jacob Van Naarden, CEO of Loxo@Lilly. “The initial adjuvant approval for Verzenio changed the treatment paradigm, and the strength of the monarchE study results supporting this approval underscore the role this differentiated CDK4/6 inhibitor can play in reducing the risk of recurrence in early breast cancer.”

Concurrently, the FDA has concurrently expanded the indicated use of abemaciclib in metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy for individuals with HR+/HER2- advanced or metastatic breast cancer. This updated indication includes all adult patients; the expanded indication includes both pre- and postmenopausal women when abemaciclib is used in combination with ovarian suppression.

More than 300,000 individuals in the United States are expected to receive a breast cancer diagnosis in 2023. Although estimates suggest that 90% of all breast cancers are detected at an early stage, high risk patients with HR+/HER2- early breast cancer are 3 times more likely to experience recurrence compared with patients with low-risk characteristics; most of these recurrences are incurable metastatic disease.

  1. US FDA broadens indication for Verzenio (abemaciclib) in HR+, HER2- node-positive high risk early breast cancer. News release. Eli Lilly. March 3, 2023. Accessed March 8, 2023. https://investor.lilly.com/news-releases/news-release-details/us-fda-broadens-indication-verzenior-abemaciclib-hr-her2-node
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