FDA approves abemaciclib with endocrine therapy for early breast cancer


On October 12, 2021, the Food and Drug Administration approved abemaciclib (Verzenio, Eli Lilly and Company) 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 ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.  

FDA also approved the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay, submitted by Agilent, Inc., as a companion diagnostic for selecting patients for this indication. 

Efficacy was evaluated in monarchE (NCT03155997), a randomized (1:1), open-label, two-cohort multicenter trial that included adult women and men with HR-positive, HER2-negative, node-positive, resected, early breast cancer with clinical and pathological features consistent with a high risk of disease recurrence. Patients were randomized to receive either 2 years of abemaciclib plus their physician’s choice of standard endocrine therapy or standard endocrine therapy alone. 

The major efficacy outcome measure was invasive disease-free survival (IDFS). In patients with high risk of recurrence and Ki-67 Score ≥20% (N=2003), the trial demonstrated a statistically significant improvement in IDFS (HR 0.626; 95% CI: 0.488, 0.803; p=0.0042). IDFS at 36 months was 86.1% (95% CI: 82.8, 88.8) for patients receiving abemaciclib plus tamoxifen or an aromatase inhibitor and 79.0% (95% CI: 75.3, 82.3) for those receiving tamoxifen or an aromatase inhibitor. Overall survival data were not mature at the time of the IDFS analysis. 

The most common adverse reactions (≥20%) were diarrhea, infections, neutropenia, fatigue, leukopenia, nausea, anemia, and headache. 

The recommended abemaciclib starting dose is 150 mg taken twice daily in combination with tamoxifen or an aromatase inhibitor until completion of 2 years of treatment or until disease recurrence, or unacceptable toxicity.  

View full prescribing information for Verzenio 

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’sMedWatch Reporting System or by calling 1-800-FDA-1088. 

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. 

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