Eli Lilly’s CDK 4 and 6 inhibitor Verzenios has been approved in Europe for the treatment of certain metastatic breast cancers.
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.
The data show that combining the drug with an AI demonstrated a greater than 28-month median PFS in patients who received initial endocrine-based therapy for metastatic disease (28.2 months vs 14.8 months for placebo/AI).
“Despite advancements in medicine, metastatic or advanced breast cancer remains a difficult-to-treat, diverse disease with a range of characteristics that can present differently in each individual,” said Dr Arash Tahbaz, senior medical director, Eli Lilly UK and Northern Europe.
“This marketing authorisation recognises the potential clinical benefit abemaciclib offers and represents continued progress towards helping more people living with this devastating disease.”