INDIANAPOLIS — The U.S. Food and Drug Administration approved an oral tablet from Eli Lilly and Company to treat certain people with high-risk, early breast cancer.
Verzenio abemaciclib, in combination with endocrine therapy, is used as treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high-risk of recurrence.
According to Eli Lilly, Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells so the cells may eventually die.
"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, senior vice president of CEO of Loxo Oncology at Lilly and president of Lilly Oncology.
Verzenio has already been approved for certain types of HR+ HER2- advanced or metastatic breast cancer. The pill is available in tablet strengths of 200 mg, 150 mg, 100 mg and 50 mg.
"Women and men living with high-risk HR+ HER2- early breast cancer want to do all they can to reduce the risk of the disease coming back, with the hope of living free of cancer. The approval of Verzenio provides a new treatment option to help them do just that," said Jean Sachs, chief executive officer of Living Beyond Breast Cancer.
The National Cancer Institute said approximately 70% of all breast cancers are of the HR+ HER2- subtype.
According to GLOBOCAN, breast cancer has surpassed lung cancer as the most commonly diagnosed cancer worldwide.
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