TheraSphere Y-90 glass microspheres. Image courtesy of Boston Scientific.
The approval makes TheraSphere the only radioembolization technique indicated for unresectable HCC in the U.S., according to the firm. Prior to the approval, TheraSphere was used under a humanitarian device exemption (HDE).
TheraSphere's approval stems from results of the LEGACY study, which evaluated the safety and efficacy of the technique's treatment of early and advanced HCC. The researchers found 100% complete or partial patient response after up to two TheraSphere treatments, with the disappearance of all lesions, or greater than or equal to 30% decrease in target lesion diameter.
In addition, researchers found a 93% overall survival rate in patients with transplant or resection following treatment at three years.
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