Posted by Michael Wonder on 10 Jul 2017
FDA grants priority review for Lilly's abemaciclib for the treatment of advanced breast cancer
10 July 2017 - Eli Lilly and Company (NYSE: LLY) today announced that the U.S. FDA has accepted and filed its new drug application for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and given the application a priority review designation.
The application includes the company's submission of abemaciclib for two indications: abemaciclib monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy.
This submission is based on the MONARCH 1 and MONARCH 2 studies, respectively.
