October 2021: Тамак-аш жана дары-дармек башкармалыгы бекитти abemaciclib (Verzenio, Eli Lilly and Company) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of less than 20%, as determined by an FDA- This is the first CDK 4/6 inhibitor to be approved for breast cancer adjuvant treatment.
Agilent, Inc. submitted the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay, which was authorised by the FDA as a companion diagnostic for this indication.
Adult women and men with HR-positive, HER2-negative, node-positive, resected, early breast cancer with clinical and pathological characteristics consistent with a high risk of disease recurrence were involved in monarchE (NCT03155997), a randomised (1:1), open-label, two-cohort multicenter trial. Patients were given either 2 years of abemaciclib plus their doctor’s choice of standard endocrine medication or normal endocrine therapy alone.
Invasive disease-free survival was the primary effectiveness outcome measure (IDFS). The trial found a statistically significant improvement in IDFS (HR 0.626; 95 percent CI: 0.488, 0.803; p=0.0042) in patients with a high risk of recurrence and a Ki-67 Score of less than 20% (N=2003). Patients receiving abemaciclib with tamoxifen or an aromatase inhibitor had an IDFS of 86.1 percent (95 percent CI: 82.8, 88.8) at 36 months, while those receiving tamoxifen or an aromatase inhibitor had an IDFS of 79.0 percent (95 percent CI: 75.3, 82.3). At the time of the IDFS analysis, the overall survival data was not complete.
Diarrhea, infections, neutropenia, tiredness, leukopenia, nausea, anaemia, and headache were the most prevalent side effects (20%).
The recommended beginning dose of abemaciclib is 150 mg twice daily in combination with tamoxifen or an aromatase inhibitor for 2 years or until disease recurrence or intolerable toxicity, whichever comes first.
