Eli Lilly has picked up approval in the US for its VerzenioTM (abemaciclib) in combination with an aromatase inhibitor as initial treatment for advanced breast cancer.
This latest approval from the US Food and Drug Administration is the third for Verzenio within five months.
In September 2017, Verzenio became the first and only cyclin-dependent kinase (CDK)4 & 6 inhibitor approved in combination and as a single agent in metastatic breast cancer.
Specifically, Verzenio was approved for use in combination with fulvestrant for the treatment of women with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
The approval is based on the efficacy and safety demonstrated in the pivotal MONARCH 3 clinical trial.
MONARCH 3 is a Phase 3, randomised, double-blind, placebo-controlled trial evaluating Verzenio in combination with an AI as initial endocrine-based therapy that enrolled 493 postmenopausal women with HR+, HER2- 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.
This Verzenio new drug application was given Priority Review as part of the FDA’s Expedited Programs for Serious Conditions.
It was also granted Breakthrough Therapy Designation in 2015 based on the Phase 1 JPBA trial.