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.
Is Artificial Intelligence a ‘Product’? Products Liability Implications for AI-Based Products
April 10th 2025As the physical products we use evolve to become increasingly complex, traditional products liability frameworks may not always fit to provide remedies for harm that can result from using novel product types.
