FDA Approved Expanded Verzenio Use

FDA has approved Eli Lilly’s Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for treating postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. This is the third indication for Verzenio within five months; in 9/2017, Verzenio became the first cyclin-dependent kinase 4 & 6 inhibitor approved in combination and as a single agent in metastatic breast cancer.

Expanded approval is based on the efficacy and safety demonstrated in the pivotal MONARCH 3 clinical trial. Data showed that Verzenio dosed orally at 150 mg twice daily on a continuous schedule with an AI demonstrated a greater than 28-month median progression-free survival in patients who received initial endocrine-based therapy for metastatic disease compared with 14.8 months for those on a placebo plus an AI.