March 6, 2018—Eli Lilly announced the FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
This additional FDA approval marks the third indication for Verzenio within five months. In September 2017, Verzenio became the first cyclin-dependent kinase (CDK) 4 and 6 inhibitor approved in combination and as a single agent in metastatic breast cancer. Specifically it was approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy and to be given on its own if patients were previously treated with endocrine therapy and chemotherapy after the cancer had metastasized.
The safety and efficacy of Verzenio in combination with an AI as initial endocrine-based therapy were based on the results of the MONARCH 3 study, a randomized trial of 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic treatment for advanced disease. In patients who received neoadjuvant/adjuvant endocrine therapy, a disease-free interval of more than 12 months since completion of endocrine therapy was required. The median progression-free survival for patients taking Verzenio with fulvestrant was 28 months as compared with 14.8 months for patients taking a placebo with fulvestrant.
This Verzenio new drug application was given priority review as part of the FDA’s Expedited Programs for Serious Conditions, a program used for therapies that address an unmet medical need in the treatment of serious or life-threatening conditions. Verzenio was also granted breakthrough therapy designation in 2015 based on the phase one JPBA trial.