Eli Lilly (NYSE:LLY) has announced that it has approved Verzenio (abemaciclib) for certain patients with HR+ HER2– high-risk early breast cancer.
The drug will become the first inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) to hit the U.S. market.
“Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options,” said Jacob Van Naarden, president of Lilly Oncology, in a statement.
The twice-daily therapy Verzenio will be available in tablet forms at 50, 100, 150 and 200-mg dose levels.
Indianapolis–based Lilly noted that the FDA approval covered the use of the drug in tandem with endocrine therapy such as tamoxifen or an aromatase inhibitor.
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