The Food and Drug Administration (FDA) has approved TheraSphere™ Y-90 Glass Microspheres, a radioembolization technology, for local tumor control of solitary tumors (1 to 8cm in diameter) in patients with unresectable hepatocellular carcinoma, Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status.

TheraSphere is a selective internal radiation therapy that is comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90). These beads are delivered through a catheter directly to liver tumors, thereby reducing exposure to surrounding tissue.

The approval was based on data from the LEGACY study, which evaluated treatment with TheraSphere Y-90 glass microspheres in 162 patients with unresectable hepatocellular carcinoma. The primary endpoints of the study were objective response rate (ORR), defined as a complete or partial response, and duration of response (DoR).

Results showed an ORR of 72.2% at 4 weeks among all enrolled patients. Additionally, 89 of the 117 patients (76.1%) who responded to treatment experienced a DoR of at least 6 months. Complete or partial response was observed in 100% of patients following up to 2 TheraSphere treatments. Findings also showed an overall survival rate of 93% in patients with transplant or resection following TheraSphere at 3 years.

“I am honored to have spearheaded the Legacy trial in which we found that patients with early and advanced HCC exhibited very high response rates as well as clinically meaningful durations of response and survival, establishing TheraSphere as a standard treatment for this patient population,” said Riad Salem, MD, MBA, interventional radiologist at Northwestern Memorial Hospital and principal investigator of the LEGACY trial. “The trial results […] produced one of the most comprehensive databases for TheraSphere, empowering physicians to make informed, data-driven decisions for their patients.”

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