FDA Approves Radioembolization Technology for Hepatocellular Carcinoma

By Cassie Homer

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The FDA approved TheraSphere Y-90 Glass Microspheres, a radioembolization technology, for the treatment of patients with hepatocellular carcinoma (HCC), according to a press release. 

The therapy was previously granted humanitarian device exemption, which limited the number of patients treated with the therapy per year. 

The technology is a type of selective internal radiation therapy comprised of microscopic glass beads containing radioactive yttrium. The beads are delivered directly to the tumors via a catheter, limiting patient toxicity.

The FDA based the approval on results from the LEGACY study, which included 162 patients. The treatment resulted in a 4-week objective response rate of 72.2% and a six-month duration of response rate of 76.1%. All patients achieved complete or partial response, defined as disappearance of all lesions or at least a 30% decrease in target lesion diameter. Among patients with transplant or resection following treatment with the radioembolization technology, the three-year overall survival rate was 93%. 

"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, which have been accepted for publication in Hepatology, produced one of the most comprehensive databases for TheraSphere, empowering physicians to make informed, data-driven decisions for their patients."

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