Policy & Regulation
US FDA Grants Breakthrough Therapy Designation to Cabozantinib for the Treatment of Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
25 February 2021 - - The US Food and Drug Administration has granted Breakthrough Therapy Designation to cabozantinib (Cabometyx) as a potential treatment for patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate), US-based Exelixis, Inc. (NASDAQ: EXEL) said.

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