Posted by Michael Wonder on 12 Oct 2017
FDA grants priority review for potential new indication for Lilly's Verzenio (abemaciclib) as initial treatment of advanced breast cancer
12 October 2017 - Eli Lilly and Company today announced that the U.S. FDA has granted priority review designation for its new drug application for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor.
The application was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
The results were presented at the European Society for Medical Oncology 2017 Congress, and recently published in the Journal of Clinical Oncology.
