The US Food and Drug Administration (FDA) has approved Eli Lilly’s Verzenio (abemaciclib) for patients suffering from hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
Verzenio is an inhibitor of cyclin-dependent kinase (CDK) 4 & 6 and comes in 50mg, 100mg, 150mg and 200mg formulations.
The current indication covers an oral 150mg two-times-a-day dose of Verzenio as initial endocrine-based treatment to be given along with an aromatase inhibitor (AI) to post-menopausal patients.
For the FDA review, Lilly submitted safety and efficacy data from the randomised, double-blind, placebo-controlled MONARCH 3 clinical trial that involved 493 subjects who did not previously receive systemic treatment for advanced conditions.
According to the trial results, patients treated with Verzenio and an AI combination demonstrated more than 28 months of median progression-free survival (PFS) compared to 14.8 months with placebo and an AI.
Eli Lilly Oncology senior vice-president and president Sue Mahony said: “The speed with which our team has been able to work with the FDA to gain approval for this additional Verzenio indication underscores Lilly’s commitment to delivering meaningful medicines that can help more people living with advanced breast cancer.
“Verzenio has now been developed, studied and clinically proven in three key trials to be effective for women with HR+, HER2- metastatic breast cancer – helping to ensure we are providing support to those who need it most.”
Verzenio was previously approved in the US as a monotherapy for adult patients having HR+, HER2- advanced or metastatic breast cancer with disease progression after endocrine therapy and chemotherapy in metastatic setting.
The FDA also approved the drug as a combination therapy with fulvestrant for treating HR+, HER2- advanced or metastatic breast cancer that progressed following endocrine therapy.