The decision gives doctors the green light to prescribe the drug for women with hormone receptor-positive (HR+), epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor (AI) or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
The applications were based on the Phase III MONARCH 2 and 3 trials.
In MONARCH 2, adding Verzenios (abemaciclib) to AstraZeneca’s Faslodex (fulvestrant) significantly improved progression-free survival compared to Faslodex plus placebo, with figures of 16.4 months versus 9.3 months, respectively.
MONARCH 3 evaluated Verzenios in combination with an AI as initial endocrine-based therapy in postmenopausal women with HR+, HER2- advanced breast cancer who had no prior systemic treatment for advanced disease…
