FDA Approves Boston Scientific’s TheraSphere Y-90 Glass Microspheres

Boston Scientific obtained U.S. Food and Drug Administration (FDA) approval for its TheraSphere Y-90 Glass Microspheres to treatment patients with hepatocellular carcinoma (HCC). Previously the technology was utilized under a humanitarian device exemption (HDE). TheraSphere is now the only radioembolization technology indicated for unresectable HCC treatment in the U.S.
 
HCC is treated through surgery, liver transplantation, chemotherapy, or embolization—including both chemoembolization and radioembolization—commonly referred to as selective internal radiation therapy (SIRT). TheraSphere treatment, a type of SIRT with low toxicity, is comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90) delivered to liver tumors via catheter, causing minimal exposure to surrounding healthy tissue.
 
Approval of TheraSphere was based on results from the LEGACY study, which evaluated the therapy’s safety and efficacy to treat 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 percent at four weeks and 76.1 percent at six months, respectively).^1,2,3,4
 
“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,” Riad Salem, M.D., M.B.A, interventional radiologist at Northwestern Memorial Hospital and principal investigator of the LEGACY trial told the press. “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.”
 
TheraSphere treatment doesn’t 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.
 
“The FDA approval and the recent NICE recommendation will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally,” said Peter Pattison, president of Interventional Oncology, Peripheral Interventions, Boston Scientific. “We expect to continue to focus our efforts on bringing this treatment to more patients, both by planning a randomized trial to study the combination of TheraSphere and immunotherapy in patients with HCC not eligible for curative treatments, as well as further investigating the therapy for different cancer segments, including prostate and brain.”
 
References
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