FDA Approves the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company'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 and a Ki-67 score of ≥20% as determined by an FDA-approved test, on October 13, 2021.
Ki-67 is a marker of cellular proliferation. And Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
"Over time, the collective results of the Verzenio clinical development program 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 represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, SVP, CEO of Loxo Oncology at Lilly and president, Lilly Oncology, in a press release.
"We are pleased with this initial approval in the adjuvant setting, and as these data continue to mature, we look forward to furthering opportunities to work with health authorities to expand the use of Verzenio in this setting."
This approval is based on efficacy results from an analysis of this subgroup with additional follow-up conducted post-hoc. In this analysis, Verzenio given in combination with ET continued to demonstrate a clinically meaningful benefit, with a 37 percent decrease in the risk of breast cancer recurrence or death compared to standard adjuvant ET alone for patients with high risk clinical and pathological features and a Ki-67 score ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), and an absolute benefit in IDFS event rate of 7.1 percent at three years.
The number of IDFS events at this analysis was 104 with Verzenio plus ET compared to 158 with ET alone. Overall survival data were not mature, and additional follow-up is ongoing.
Adverse reactions from monarchE were consistent with the known safety profile for Verzenio.2 Safety and tolerability were evaluated in 5,591 patients.
For more than 50 years, Indiana-based Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world.
To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.