Lilly: FDA Approves Verzenio in Some High-Risk Early Breast-Cancer Patients

 Eli Lilly and Co. on Wednesday said the U.S. Food and Drug Administration approved the expanded use of its cancer drug Verzenio in combination with endocrine therapy in certain patients with high-risk early breast cancer.

The Indianapolis drug maker said the approval covers the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of at least 20%.

Eli Lilly said Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.

The FDA previously approved Verzenio for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer. Eli Lilly said the agency has now expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men.

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