FDA Approves VERZENIO® for Hormone Receptor Positive, HER2-Negative Breast Cancer

November 1st, 2017

The FDA in September 2017, approved VERZENIO® (Abemaciclib) in combination with FASLODEX® (Fulvestrant) for women with Hormone Receptor positive (HR-positive), HER2-negative, advanced or metastatic breast cancer, with disease progression following endocrine therapy. In addition, VERZENIO® was approved as monotherapy for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer, with disease progression following endocrine therapy and prior chemotherapy, in the metastatic setting. The approval of VERZENIO® in combination with FASLODEX® was based on MONARCH 2 study which showed that a combination of VERZENIO® plus FASLODEX® significantly improved Progression Free Survival and Objective Response Rates, with a tolerable safety profile, in patients with Hormone Receptor-positive and HER 2-negative metastatic breast cancer, who had progressed while receiving endocrine therapy.