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FDA approves Eli Lilly’s Verzenio in high risk early breast cancer

Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- early breast cancer

Eli Lilly

The US Food and Drug Administration (FDA) has approved Eli Lilly's Verzenio (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence.

Adding Verzenio to endocrine therapy (ET) demonstrated a significant and clinically meaningful reduction in the risk of recurrence.

"Over time, the collective results of the Verzenio clinical development programme have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represents another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, senior vice president, CEO of Loxo Oncology at Lilly and president, Lilly Oncology.

The phase 3 monarchE trial is a randomised multicentre study in adult women and men. In the trial, patients received either two years of Verzenio 150 mg twice daily plus standard endocrine therapy, or standard endocrine therapy alone.

Verzenio given in combination with ET resulted in a 37% decrease in the risk of breast cancer recurrence or death compared to standard adjuvant ET alone for patients at high risk.

Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. Data supporting this approval will be presented at the European Society for Medical Oncology (ESMO).

“The design and results of the monarchE study are practice-changing and represent the first advancement in adjuvant treatment of HR+ HER2- breast cancer in a very long time,” said Sara Tolaney, Harvard Medical School, Dana-Farber Cancer Institute, and investigator on the monarchE study.

"This FDA approval for Verzenio in combination with endocrine therapy in the early breast cancer setting has the potential to become a new standard of care for this population,” she added.

This FDA approval builds on the established body of evidence for Verzenio, which is already approved for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer.

“Women and men living with high risk HR+ HER2- early breast cancer want to do all they can to reduce the risk of the disease coming back, with the hope of living free of cancer,” said Jean Sachs, chief executive officer, Living Beyond Breast Cancer.

“The approval of Verzenio provides a new treatment option to help them do just that … and it brings new optimism to the breast cancer community,” she added.

Article by
Iona Everson

14th October 2021

From: Research

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