FDA approves Verzenio for certain patients with early breast cancer
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The FDA approved abemaciclib in combination with endocrine therapy for adjuvant treatment of certain patients with early breast cancer.
The approval applies to use of the agent by adults with hormone receptor-positive, HER2-negative, node-positive disease at high risk for recurrence who have a Ki-67 score of at least 20% as determined by an FDA-approved test.
Abemaciclib (Verzenio, Eli Lilly) is the first cyclin-dependent kinase 4/6 inhibitor approved for this patient population.
The FDA based the approval on results of the randomized phase 3 monarchE trial, which included adult women and men with hormone receptor-positive, HER2-negative, node-positive resected early breast cancer at high risk for recurrence.
Researchers assigned half of the patients to abemaciclib dosed at 150 mg twice daily for 2 years, plus physician’s choice of standard endocrine therapy for 5 to 10 years. The other half of patients received endocrine therapy alone.
Results of a prespecified interim analysis showed a statistically significant improvement in invasive DFS, the study’s primary endpoint, with abemaciclib in the intent-to-treat population.
Researchers then performed a subgroup analysis of patients with high-risk clinical and pathologic factors and a Ki-67 score of at least 20%. This analysis included patients with at least four positive axillary lymph nodes, or one to three positive axillary lymph nodes plus either grade 3 disease and/or tumor size of at least 5 cm.
Results continued to show statistically significant improvement in invasive DFS with abemaciclib (HR = 0.64; 95% CI, 0.47-0.87).
Additional follow-up conducted post-hoc showed a significant reduction in risk for breast cancer recurrence or death with the addition of abemaciclib to standard endocrine therapy (HR = 0.62; 95% CI, 0.49-0.8), with an absolute benefit in invasive DFS rate of 7.1% at 3 years.
Follow-up for OS is ongoing.
The most common adverse events reported among patients assigned abemaciclib plus endocrine therapy included diarrhea, infections, fatigue, nausea, headache, vomiting, stomatitis, decreased appetite, dizziness, rash and alopecia.
"The design and results of the monarchE study are practice-changing and represent the first advancement in adjuvant treatment of [hormone receptor-positive, HER2-negative] breast cancer in a very long time," study investigator Sara M. Tolaney, MD, MPH, chief of the division of breast oncology at Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School, said in an Eli Lilly-issued press release. "This FDA approval for Verzenio in combination with endocrine therapy in the early breast cancer setting has the potential to become a new standard of care for this population. We are encouraged by the marked reduction in the risk of recurrence even beyond the 2-year treatment period in these patients, and I'm grateful to be able to offer this as a treatment option to my patients.”
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