The FDA has expanded the indications for abemaciclib (Verzenio, Eli Lilly) in early and metastatic breast cancer, according to a press release from Eli Lilly. Abemaciclib no longer requires results from a biomarker test to treat certain patients with early breast cancer (EBC), and abemaciclib can now be used to treat patients with metastatic breast cancer (MBC), regardless of menopausal status.

The FDA approved an expanded indication for abemaciclib in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive EBC at a high risk for recurrence. High-risk patients eligible for abemaciclib can now be identified solely based on nodal status, tumor size and tumor grade (more than four positive nodes, or one to three positive nodes and at least one of the following: tumors that are ≥5 cm or grade 3). The expanded adjuvant indication removes the Ki-67 score requirement for patient selection.

This label expansion is supported by four-year data from the phase 3 monarchE trial of adjuvant abemaciclib in combination with ET, which showed a deepened benefit in invasive disease–free survival (IDFS) beyond the two-year treatment course with adjuvant abemaciclib. The absolute difference in IDFS between treatment groups increased over time. At four years, 85.5% of patients remained recurrence-free with abemaciclib plus ET, compared with 78.6% with ET alone. At two years and three years, the absolute differences between treatment groups were 3.1% and 5.0%, respectively. The addition of abemaciclib to ET reduced the risk for recurrence by 35% compared with ET alone (hazard ratio, 0.653; 95% confidence interval, 0.567-0.753). There were no new safety findings. The four-year monarchE data were presented at the 2022 San Antonio Breast Cancer Symposium and simultaneously published in the Lancet Oncology (2023;24[1]:77-90).

Concurrent with this expanded indication approval in EBC, the FDA has also broadened the indicated use of abemaciclib in MBC when used in combination with an aromatase inhibitor as initial ET for the treatment of people with hormone receptor–positive, HER2-negative advanced breast cancer or MBC. This updated MBC indication now includes all adult patients, with the expanded indication including pre-/perimenopausal women when used in combination with ovarian suppression. 

—Clinical Oncology News Staff

Based on a press release from Eli Lilly.