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FDA Approves Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Jason M. Broderick @jasoncology
Published: Monday, Feb 26, 2018

Joyce O’Shaughnessy, MD,

Joyce O’Shaughnessy, MD,
The FDA has approved abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

"This approval is an important milestone, as it shows that Verzenio plus an aromatase inhibitor substantially reduced tumor size and delayed disease progression in women with HR+, HER2- metastatic breast cancer. Notably, the MONARCH 3 trial included patients with certain concerning clinical characteristics, such as a pattern of disease that spread to the liver," Joyce O'Shaughnessy, MD, Celebrating Women Chair in Breast Cancer Research and chair, Breast Cancer Research Program, Baylor University Medical Center, TexasOncology and US Oncology, said in a statement.

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