Research & Development
Eli Lilly wins FDA approval of Verzenio for treatment of HR+ HER2- high risk early breast cancer
14 October 2021 -

Health care company Eli Lilly and Company (NYSE: LLY) reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) approval for Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of certain people with breast cancer.

Specifically, the treatment was approved for 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. Ki-67 is a marker of cellular proliferation.

Verzenio is the first and only CDK4/6 inhibitor approved for this patient population, Eli Lilly said. It is available in tablet strengths of 200 mg, 150 mg, 100 mg and 50 mg.

Verzenio is already approved for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer. Concurrent with this latest approval, the FDA has expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men.

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