The European Commission approves the use of abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor-positive (HR) early stage breast cancer and non-expressing human epidermal growth factor receptor 2 (HER2) type 2 receptor with lymph node metastasis, with a high risk of relapse.
Abemaciclib is the first and only inhibitor of CDK4 and 6 in the therapy of HR +, HER2- early breast cancer with a high risk of recurrence. The positive opinion of the European Medicines Agency was based on the results of the monarchE 1 Phase 3 trial, which met its primary endpoint in the second intermediate efficacy analysis, showing statistically significant improvement in free survival from Invasive Disease (IDFS).
For the monarchE study of 2 patient cohorts, 5,637 female and male patients with...
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