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Eli Lilly breast cancer drug gets US FDA priority review stamp

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Eli Lilly breast cancer drug gets US FDA priority review stamp

Eli Lilly & Co. said the U.S. Food and Drug Administration granted priority review designation for its new drug application for Verzenio to treat breast cancer.

The application was based on the positive interim results of the MONARCH 3 study on Verzenio, or abemaciclib, combined with an aromatase inhibitor as initial endocrine-based therapy for treating women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

Lilly had completed the EU and Japan regulatory submissions for the drug during the third quarter.

About 252,710 new cases of invasive breast cancer are expected to be diagnosed in the U.S. in women in 2017.