Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval of the TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). The approval expands access to this life-prolonging therapy for several patients, which, to date, has been utilized under a humanitarian device exemption (HDE) – an FDA classification requiring institutional review board approval and limited the number of patients treated with the therapy per year. TheraSphere is now the only radioembolization technology indicated for the treatment of unresectable HCC in the U.S.
HCC is one of the most prevalent cancers and the most common type of primary liver cancer most often treated, through surgery, liver transplantation, chemotherapy or embolization, including both chemoembolization and radioembolization – also referred to as selective internal radiation therapy (SIRT). TheraSphere treatment, a type of SIRT with low toxicity comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90), which are delivered directly to liver tumors via a 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.
Riad Salem, M.D., M.B.A, Interventional Radiologist, Northwestern Memorial Hospital and Principal Investigator of the LEGACY trial, said: “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 the clinically meaningful duration of response and survival, establishing TheraSphere as a standard treatment for this patient population. 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.
Peter Pattison, President of Interventional Oncology, Peripheral Interventions, Boston Scientific, said: “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. 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.”