FDA Expands Abemaciclib Approval to Include HR+ HER2– Node+ High-Risk Breast Cancer

The FDA has approved an expanded indication for adjuvant abemaciclib (Verzenio) plus endocrine therapy for hormone receptor–positive, HER2-negative, node-positive high-risk early breast cancer, according to a press release from Eli Lilly.

"The magnitude of benefit seen in the four-year data from the monarchE study reinforces my confidence in adjuvant [abemaciclib] as the standard of care for high-risk patients in this setting," according to an expert from Sarah Cannon Research Institute.

The expanded label was based on 4-year follow-up findings from the phase 3 monarchE study (NCT03155997), which assessed adjuvant abemaciclib plus endocrine therapy in a post-surgical population of patients with breast cancer. Investigators reported that 85.5% of patients were recurrence-free at 4 years in the abemaciclib arm compared with 78.6% in the endocrine therapy alone arm.

The risk of recurrence decreased by 35% with the abemaciclib combination vs endocrine therapy alone (HR, 0.653; 95% CI, 0.567-0.753).

“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 four-year data from the monarchE study reinforces my confidence in adjuvant [abemaciclib] as the standard of care for high-risk patients in this setting,” Erika P. Hamilton, MD, medical oncologist and director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, said in the press release.

investigators reported no new safety findings and found the profile to be consistent with previous reports for abemaciclib.

Reference

U.S. FDA broadens indication for Verzenio^® (abemaciclib) in HR+, HER2-, node-positive, high risk early breast cancer. News release. Eli Lilly and Company. March 3, 2023. Accessed March 3, 2023. http://bit.ly/3Ypwzsd