The Food and Drug Administration has given the green light for 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-positive), human epidermal growth factor receptor 2-negative (HER2-negative), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation.
Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
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"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, senior vice president, CEO of Loxo Oncology at Lilly and president, Lilly Oncology. "We are pleased with this initial approval in the adjuvant setting and as these data continue to mature, we look forward to further opportunities to work with health authorities to expand the use of Verzenio in this setting."
Verzenio already is approved for the treatment of certain types of HR-positive, HER2-negative advanced or metastatic breast cancer. Concurrent with this approval, the FDA has expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men. Verzenio is available in tablet strengths of 200 mg, 150 mg, 100 mg, and 50 mg.
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"The design and results of the monarchE study are practice-changing and represent the first advancement in adjuvant treatment of HR-positive, HER2-negative 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. We are encouraged by the marked reduction in the risk of recurrence even beyond the two-year treatment period in these patients, and I'm grateful to be able to offer this as a treatment option to my patients."