FDA Grants Breakthrough Therapy Designation to Cabozantinib in Differentiated Thyroid Cancer
Posted: Thursday, March 11, 2021
Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the small-molecule RTK inhibitor cabozantinib as a potential therapy for patients with resistant differentiated thyroid cancer. These patients experienced disease progression after prior therapy, and their disease was refractory to radioactive iodine (RAI).
Late in 2020, the phase III COSMIC-311 trial (ClinicalTrials.gov identifier NCT03690388) met its co-primary endpoint. There was a significant reduction in the risk of disease progression or death of 78% with cabozantinib versus placebo (hazard ratio = 0.22, 96% confidence interval = 0.13–0.36, P < .0001) in patients with RAI-refractory differentiated thyroid cancer who experienced disease progression after up to two prior VEGFR-targeted therapies. The safety profile was reported to be consistent with that previously observed with cabozantinib.