OR WAIT 15 SECS
October 08, 2015.
FDA has granted Breakthrough Therapy Designation to Eli Lilly and Company's abemaciclib for patients with refractory hormone-receptor-positive advanced or metastatic breast cancer.
The Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat a serious condition, and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
FDA's decision is based on data from the breast cancer cohort expansion of Lilly's Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer.