Eli Lilly and Company (LLY) said the FDA has approved its Verzenio, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of at or above 20%.
Verzenio is already approved for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer. The FDA has expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men.
Jacob Van Naarden, CEO of Loxo Oncology at Lilly and president, Lilly Oncology, said: "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."
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