Abemaciclib for HR+ breast cancer in EUDecember 13, 2018
EMA has cleared abemaciclib (Verzenio) to treat women with hormone receptor-positive (HR+), epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.
The treatment with CDK4/6inhibitor is approved as a first-line therapy in combination with an aromatase inhibitor or fulvestrant, and as a second-line treatment after earlier endocrine drugs.
The approval of abemaciclib is based on the results of the Monarch 2 and Monarch 3 as second-line and first-line studies. A phase III trial called Monarch E is currently underway to determine the efficacy of abemaciclibas adjuvant therapy in early breast cancer.
Earlier, Eli Lilly suspended the Phase 3 Juniper programme to extend the use of abemaciclibinto pancreatic cancer as it failed to meet the endpoints