FDA Grants Breakthrough Therapy Designation to Lilly Cancer Drug

October 8, 2015

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.