(Breast Cancer) FDA Approves Verzenio Combined With Endocrine Therapy

On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved Verzenio (abemaciclib) combined with hormone therapy as adjuvant treatment for patients with hormone receptor (HR)-positive, HER2-negative, lymph node-positive early breast cancer at high risk of recurrence with a Ki67 index greater than 20%. This is the first CDK4/6 inhibitor to receive FDA approval for adjuvant therapy in breast cancer.

Additionally, the FDA approved the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay submitted by Agilent, Inc. as a companion diagnostic to identify patients eligible for this therapy.

This approval was based on the monarchE (NCT03155997) clinical trial, a multi-center, randomized, open-label, dual-cohort study evaluating efficacy in female and male patients with HR+, HER2-negative, node-positive early breast cancer after surgical resection who were at high risk of recurrence based on clinical and pathological features. Patients were randomized to the Verzenio group (Verzenio plus standard endocrine therapy, 2-year treatment duration) or the standard endocrine therapy group (2-year treatment duration).

Efficacy:

The primary endpoint was invasive disease-free survival (IDFS). In patients at high risk of recurrence with Ki67 index >20% (N=2,003), IDFS was significantly improved. At 36 months, the IDFS rates were: Verzenio group 86.1% vs. standard endocrine therapy group 79.0%. Overall survival (OS) was not yet reached.

Safety:

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

Dosing: The recommended Verzenio dose is 150 mg twice daily combined with standard endocrine therapy for 2 years, until disease recurrence or unacceptable toxicity.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer

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