Verzenio Receives New Indication
February 26, 2018 – The U.S. FDA has approved a new indication for Verzenio™ (abemaciclib), manufactured by Eli Lilly. The drug is now approved for use in combination with an aromatase inhibitor (AI) as a first-line treatment for postmenopausal women who have advanced or metastatic hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
The FDA based the new indication’s approval on a clinical trial in which treatment with Verzenio and AIs improved progression-free survival rates and duration of response compared to AIs with placebo. For patients who had measurable disease, treatment with Verzenio and AIs was shown to substantially reduce tumor sizes.
Verzenio was first approved in 2017, and holds two additional indications for the treatment of advanced or metastatic HR-positive, HER2-negative breast cancer.
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