Cancer Drug Still Denied Approval By FDA

Source: PharmaManufacturing.com

Jun 11, 2013

USA Today

On Monday, Aveo Oncology announced that the Food and Drug Administration had again refused to grant their cancer drug tivozanib approval. The FDA claimed clinical trial data supporting the drug was not clear enough to warrant approval as requested. 

Aveo is seeking approval for tivozanib as a treatment for the most common type of kindney cancer, advanced renal cell carcinoma. The FDA has recommeneded Aveo run a new clinical trial of tivozanib because the previous late-stage trial was not able to draw meaningful conclusions due to inconsistent survival data and differences in patients' therapies following treatment. Read the full story.