The FDA's Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat serious or life-threatening diseases.
To qualify for this designation, preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement on at least one clinically significant endpoint over existing therapies.
In December 2020, Exelixis announced that at a planned interim analysis, the phase 3 COSMIC-311 pivotal trial met the co-primary endpoint, demonstrating a significant reduction in the risk of disease progression or death of 78% with cabozantinib versus placebo (HR 0.22, 96% CI 0.13 0.36; p
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