Posted by Michael Wonder on 27 Feb 2018
Lilly receives additional FDA approval for Verzenio (abemaciclib), as initial treatment for advanced breast cancer
26 February 2018 - New indication based on MONARCH 3 trial can help more women living with HR+, HER2- advanced breast cancer.
Eli Lilly and Company today announced that the U.S. FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of post-menopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) 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 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.
