FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer.

ABSTRACT:

Purpose

The US Food and Drug Administration approved abemaciclib in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score ≥ 20%.

Patients and methods

The approval was based on monarchE, a phase III, open-label, 2-cohort, multicenter trial of patients with EBC randomly assigned to receive abemaciclib plus ET (n = 2,808) or ET alone (n = 2,829). Abemaciclib was given at 150 mg orally twice daily for 2 years.

Results

Invasive disease-free survival (IDFS) in the intent-to-treat population was statistically significant at the second IDFS interim analysis (IA; March 2020; hazar

SUBMITTER: Royce M 

PROVIDER: S-EPMC8987222 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature