Eli Lilly has announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for abemaciclib and has granted it Priority Review.
Abemaciclib is a selective ATP-competitive inhibitor of CDK4 and CDK6 cyclin-dependent kinases, aimed at preventing phosphorylation and inactivation of the retinoblastoma protein (Rb) tumor suppressor protein. The oral cell cycle inhibitor was found to sustain target inhibition and reduce phosphorylation of Rb leading to cell cycle arrest.
The accepted NDA was submitted for two indications: as monotherapy for patients with hormone-receptor positive (HR+), human epidermal growth factor receptor 2- negative (HER2-) advanced breast cancer with prior endocrine and chemotherapy for metastatic disease, and as combination therapy with fulvestrant in HR+, HER2- advanced breast cancer with disease progression after endocrine therapy. The NDA included data from two trials, MONARCH 1 and MONARCH 2, which are a part of the comprehensive MONARCH clinical trial program.
Abemaciclib was granted Breakthrough Therapy Designation by the FDA in 2015 based on a Phase 1 trial, JPBA, studying the efficacy and safety in women with advanced or metastatic breast cancer. The Breakthrough Therapy Designation made abemaciclib eligible for Priority Review. A Phase 3 study of abemaciclib in lung cancer is currently ongoing.
For more information call (800) 545-5979 or visit Lilly.com.