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FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Jason M. Broderick @jasoncology
Published: Thursday, Oct 12, 2017

Levi Garraway, MD, PhD

Levi Garraway, MD, PhD
The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of 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.

The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.
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