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FDA Grants Breakthrough Therapy Designation to Lilly Cancer Drug


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.


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