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

October 12, 2017 – 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 … (leggi tutto)