Radioembolization Technology for HCC Gets FDA Clearance

Boston Scientific Corporation has received US FDA approval of the TheraSphere™ Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). According to the company, TheraSphere is now the only radioembolization technology indicated for the treatment of unresectable HCC in the US. Previously, it has been used for patients under a humanitarian device exemption (HDE) – an FDA classification which required institutional review board approval and limited the number of patients treated with the therapy per year.

TheraSphere treatment, a type of SIRT with low toxicity, is comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90), which are delivered directly to liver tumors via catheter and result in minimal exposure to surrounding healthy tissue.

Approval of TheraSphere was based on results from the LEGACY study, designed to evaluate the safety and efficacy of the therapy for the treatment of early and advanced HCC. The study analyzed data from 162 patients and met both primary endpoints of objective response rate and duration of response rate (72.2% at four weeks and 76.1% at six months, respectively)^1-4. Data demonstrated 100% complete or partial patient response up to two TheraSphere treatments – disappearance of all lesions or >/= 30% decrease in target lesion diameter – and a 93% overall survival rate in patients with transplant or resection following treatment at three 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, M.D., M.B.A, 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."

Treatment with TheraSphere does not require hospitalization and is typically performed as an outpatient procedure in as little as an hour, potentially alleviating pressure on healthcare systems in an increasingly complex care environment. Recognition of the benefits of SIRT – both to patients and hospitals – were reflected in recently issued guidance from the National Institute for Health and Care Excellence (NICE) when they recommended the use of TheraSphere for the treatment of patients with HCC through the National Health Service (NHS) in England, Wales and Northern Ireland.

1. Complete Response (CR) and Partial Response (PR) within the treatment area according to localized mRECIST.
2. Duration of Response (DoR) According to localized mRECIST.
3. Objective Response Rate defined as CR or PR using localized mRECIST (defined as the response within theY-90 glass microsphere treatment area) with confirmation of response (>4 weeks).
4. Duration of Response using localized mRECIST.